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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
Model TWBD1021, TWBD1022, TWBD1017, TWBD1018, TWBD1019
Device Name SURGICLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
Applicant
COVALON TECHNOLOGIES, INC.
405 britannia rd. east
suite 106
mississauga, ontario, 
Contact christopher fredric
Classification Product Code
FRO  
Date Received06/21/2012
Decision Date 08/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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