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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing Kit
510(k) Number K951022
Device Name CIRCULON SYSTEM STEP 1
Applicant
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
P.O. BOX 4000
PRINCETON,  NJ  08540
Applicant Contact ADRIENNE MCNALLY
Correspondent
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
P.O. BOX 4000
PRINCETON,  NJ  08540
Correspondent Contact ADRIENNE MCNALLY
Regulation Number880.5075
Classification Product Code
MCY  
Date Received03/07/1995
Decision Date 06/12/1995
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty General Hospital
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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