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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 -5529
Applicant Contact ELIZABETH H ANDERSON
Correspondent
BEIERSDORF, INC.
360 DR. MARTIN LUTHER KING DR.
P.O. BOX 5529
NORWALK,  CT  06856 -5529
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
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