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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Beads, Hydrophilic, For Wound Exudate Absorption
510(k) Number K903645
Device Name DERMASORB WOUND CONTACT LAYER DRESSING
Applicant
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
P.O. BOX 4000
PRINCETON,  NJ  08540
Applicant Contact MARILYN B DREYLING
Correspondent
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
P.O. BOX 4000
PRINCETON,  NJ  08540
Correspondent Contact MARILYN B DREYLING
Regulation Number878.4018
Classification Product Code
KOZ  
Date Received08/14/1990
Decision Date 11/21/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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