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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 K944588
Device Name STERILE PLASTIC DRESSING
Applicant
SMITH & NEPHEW, INC.
2100, 52ND AVE., LACHINE
QUEBEC,  CA H8T 2Y5
Applicant Contact JEAN-PIERRE DESMARAIS
Correspondent
SMITH & NEPHEW, INC.
2100, 52ND AVE., LACHINE
QUEBEC,  CA H8T 2Y5
Correspondent Contact JEAN-PIERRE DESMARAIS
Regulation Number880.5240
Classification Product Code
KGX  
Date Received09/19/1994
Decision Date 11/07/1994
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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