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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 K843876
Device Name LEUKOFLEX SURGICAL TAPE
Applicant
BEIERSDORF, INC.
P.O. BOX 5529
NORWALK,  CT  06856 -
Applicant Contact JOHN R TREMBLEY
Correspondent
BEIERSDORF, INC.
P.O. BOX 5529
NORWALK,  CT  06856 -
Correspondent Contact JOHN R TREMBLEY
Regulation Number880.5240
Classification Product Code
KGX  
Date Received10/02/1984
Decision Date 02/21/1985
Decision Substantially Equivalent (SESE)
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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