510(k) clearances

ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC

Foshan United Medical Technologies, Ltd. · Unknown

K233111Substantially EquivalentTraditionalFRO
Open FDA's page for this record
Third party flag
N
City
Guangdong Province
Advisory committee description
Unknown
Address 1
Southern Medical Devices Industrial Park
Address 2
89 Taoyuan E. Rd., Shishan, Nanhai
Statement or summary
Summary
Product code
FRO
Zip code
528225
Applicant
Foshan United Medical Technologies, Ltd.
Decision date
2024-05-24
Decision code
SESE
Country code
CN
Contact
Albert Rego
K number
K233111
Date received
2023-09-27
Review advisory committee
SU
Postal code
528225
Decision description
Substantially Equivalent
Clearance type
Traditional
Device name

ALGS2 Ag Alginate Wound Dressing Rx; ALGS2 Ag Alginate Wound Dressing OTC; ALGS2S Re-enforced Ag Alginate Wound Dressing Rx; ALGS2S Re-enforced Ag Alginate Wound Dressing OTC

Harmonized identifiers (openFDA)
Device name
Dressing, Wound, Drug
Medical specialty description
Unknown
Device class
U
Registration number
3009461428, 3006621348, 3043622938, 3007841320, 3004637474, 3030067857, 3006946276, 1314417, 3006506075, 3002636527, 3010067148, 3007048057, 1066648, 3009931872, 3017517906, 3043226252, 3044026004, 3010400367, 3042953785, 3007963765, 9610825, 8043396, 3004496953, 3013133723, 3027815, 3009610508, 3018167761, 3016450032, 3009756327, 3003755939, 3031757047, 1036836, 3043618351, 9618003, 3009167225, 2431014, 3005920706, 3011210302, 3010132111, 3008750913 +354 more
FEI number
3009461428, 3006621348, 3043622938, 3007841320, 3004637474, 1000208624, 3030067857, 3006946276, 1314417, 3006506075, 1000148471, 3002636527, 3010067148, 3007048057, 3009931872, 3017517906, 3005568854, 3043226252, 3044026004, 3010400367, 3042953785, 3007963765, 3002806731, 1019820, 3004017406, 3004496953, 3013133723, 3009610508, 3003188818, 3018167761, 3016450032, 3003040625, 3003755939, 3003264198, 3031757047, 1036836, 3043618351, 1000514656, 3002768455, 3009167225 +353 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.