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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 K853644
Device Name NITTO SURGICAL PLASTIC TAPE ST-356
Applicant
NITTO DENKO AMERICA, INC.
SAN FRANCISCO BRANCH
2900 CORVIN DRIVE
SANTA CLARA,  CA  95051
Applicant Contact KOGAMI
Correspondent
NITTO DENKO AMERICA, INC.
SAN FRANCISCO BRANCH
2900 CORVIN DRIVE
SANTA CLARA,  CA  95051
Correspondent Contact KOGAMI
Regulation Number880.5240
Classification Product Code
KGX  
Date Received09/03/1985
Decision Date 09/19/1985
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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