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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 K864913
Device Name CUTINOVA(R) PLUS FOAM GELFILM
Applicant
Beiersdorf, Inc.
360 Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Applicant Contact VINCENT MILANO
Correspondent
Beiersdorf, Inc.
360 Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
Correspondent Contact VINCENT MILANO
Classification Product Code
FRO  
Date Received12/16/1986
Decision Date 07/24/1987
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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