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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
Applicant Contact KENNETH M NICOLL
Correspondent
Beiersdorf, Inc.
360 Dr. Martin Luther King Dr.
P.O. Box 5529
Norwalk,  CT  06856
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
Predetermined Change
Control Plan Authorized		 No
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