510(k) clearances

Bonvadis®

Stemcyte, Inc. · Unknown

K232655Substantially EquivalentTraditionalFRO
Open FDA's page for this record
Third party flag
N
City
Baldwin Park
Advisory committee description
Unknown
Address 1
13800 Live Oak Ave.
Statement or summary
Summary
Product code
FRO
Zip code
91706
Applicant
Stemcyte, Inc.
Decision date
2024-05-22
Decision code
SESE
Country code
US
Device name
Bonvadis®
Contact
Angel Hsieh
K number
K232655
State
CA
Date received
2023-08-31
Review advisory committee
SU
Postal code
91706
Decision description
Substantially Equivalent
Clearance type
Traditional
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.