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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 K904500
Device Name ELASTOPLAST
Applicant
BEIERSDORF, INC.
360 MARTIN LUTHER KING DR.
P.O. BOX 5529
NORWALK,  CT  06856
Applicant Contact VINCENT VILANO
Correspondent
BEIERSDORF, INC.
360 MARTIN LUTHER KING DR.
P.O. BOX 5529
NORWALK,  CT  06856
Correspondent Contact VINCENT VILANO
Regulation Number880.5240
Classification Product Code
KGX  
Date Received10/02/1990
Decision Date 11/21/1990
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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