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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tape and bandage, adhesive
510(k) Number K940378
Device Name COVERLET ADHESIVE DRESSING
Applicant
BEIERSDORF, INC.
360 DR. MARTIN LUTHER KING DR.
P.O. BOX 5529
NORWALK,  CT  06856 -5529
Applicant Contact KENNETH M NICOLL
Correspondent
BEIERSDORF, INC.
360 DR. MARTIN LUTHER KING DR.
P.O. BOX 5529
NORWALK,  CT  06856 -5529
Correspondent Contact KENNETH M NICOLL
Regulation Number880.5240
Classification Product Code
KGX  
Date Received01/26/1994
Decision Date 07/29/1994
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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