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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name dressing, wound, drug
510(k) Number K121819
Device Name SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
Original Applicant
COVALON TECHNOLOGIES, INC.
405 britannia rd. east
suite 106
mississauga, ontario,  CA l4z 3e6
Original Contact christopher fredric
Classification Product Code
FRO  
Date Received06/21/2012
Decision Date 08/13/2012
Decision substantially equivalent (SESE)
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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