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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 K842967
Device Name AQUAPHOR R GAUZE
Applicant
Beiersdorf, Inc.
P.O. Box 5529
Norwalk,  CT  06856
Applicant Contact JOHN TREMBLEY
Correspondent
Beiersdorf, Inc.
P.O. Box 5529
Norwalk,  CT  06856
Correspondent Contact JOHN TREMBLEY
Classification Product Code
FRO  
Date Received07/27/1984
Decision Date 11/08/1984
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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