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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bandage, Liquid
510(k) Number K952526
Device Name CUTINOVA CAVITY
Applicant
Beiersdorf, Inc.
360 Dr. Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Applicant Contact ELIZABETH H ANDERSON
Correspondent
Beiersdorf, Inc.
360 Dr. Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Correspondent Contact ELIZABETH H ANDERSON
Regulation Number880.5090
Classification Product Code
KMF  
Date Received06/01/1995
Decision Date 08/14/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General Hospital
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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