IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER


Device Classification Name

dressing, wound, drug

510(k) Number K112549
Device Name IV CLEAR ANTIMICROBIAL CLEAR SILICONE ADHESIVE DRESSING WITH CHLORHEXIDINE AND SILVER
Applicant
COVALON TECHNOLOGIES, INC.
405 britannia rd. east
suite 106
mississauga, ontario, 

CA

l4z 3e6

Applicant Contact kim crooks
Correspondent
COVALON TECHNOLOGIES, INC.
405 britannia rd. east
suite 106
mississauga, ontario, 

CA

l4z 3e6

Correspodent Contact kim crooks
Classification Product Code
FRO  
Date Received 09/01/2011
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