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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Intravascular Catheter Securement
510(k) Number K925992
Device Name DUODERM TRANSPARENT HYDROCOLLOID DRESSING
Applicant
Convatec, A Division of E.R. Squibb & Sons
P.O. Box 4000
Princeton,  NJ  08540
Applicant Contact STEVEN R PELTIER
Correspondent
Convatec, A Division of E.R. Squibb & Sons
P.O. Box 4000
Princeton,  NJ  08540
Correspondent Contact STEVEN R PELTIER
Regulation Number880.5210
Classification Product Code
KMK  
Date Received11/25/1992
Decision Date 10/15/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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