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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 K112549
FOIA Releasable 510(k) K112549
Device Name IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
Applicant
Covalontechnologies, Inc.
405 Britannia Rd. E.
Suite 106
Mississauga, Ontario,  CA L4Z 3E6
Applicant Contact KIM CROOKS
Correspondent
Covalontechnologies, Inc.
405 Britannia Rd. E.
Suite 106
Mississauga, Ontario,  CA L4Z 3E6
Correspondent Contact KIM CROOKS
Classification Product Code
FRO  
Date Received09/01/2011
Decision Date 05/04/2012
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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