510(k) clearances

PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)

Primed Medical Products, Inc. · General Hospital

K233777Substantially EquivalentTraditionalFRG
Open FDA's page for this record
Third party flag
N
City
Edmonton
Advisory committee description
General Hospital
Address 1
200, 2003 91 St. SW
Statement or summary
Summary
Product code
FRG
Zip code
T6X0W8
Applicant
Primed Medical Products, Inc.
Decision date
2024-05-24
Decision code
SESE
Country code
CA
Device name
PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600)
Advisory committee
HO
Contact
Mitra Fard
K number
K233777
Date received
2023-11-24
Review advisory committee
HO
Postal code
T6X0W8
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Wrap, Sterilization
Medical specialty description
General Hospital
Regulation number
880.6850
Device class
2
Registration number
1051614, 3010363542, 9610612, 9616088, 3018094310, 3027234828, 3013298431, 1527185, 3002579136, 3004122598, 2437780, 3018781093, 3015058854, 3042191618, 3005599545, 3014421917, 1032227, 2029015, 3005180920, 2523664, 3005748481, 3042285072, 3036622014, 1055236, 3004362278, 3036679484, 3006425876, 3021361802, 3016761372, 3010864832, 3006400329, 3012315097, 3019848304, 3043226252, 9611959, 8022129, 3004634710, 3008770655, 2032364, 3007034244 +157 more
FEI number
1051614, 3010363542, 3018094310, 3027234828, 3003323921, 3013298431, 1527185, 3002579136, 3004122598, 1000160458, 1000110722, 3002805559, 3015058854, 3005599545, 3018781093, 3042191618, 3014421917, 1032227, 3005180920, 2523664, 3005748481, 3042285072, 2523865, 3036622014, 3004362278, 3036679484, 3006425876, 3021361802, 3016761372, 3006400329, 6499, 3012315097, 3019848304, 3043226252, 3001236905, 3004634710, 3008770655, 3007034244, 3004201548, 3038138452 +157 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.