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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 K860804
Device Name MEDICAL ADHESIVE TAPE
Applicant
W.R. Grace & Co.-Conn.
55 Hayden Ave.
Lexington,  MA  02173
Applicant Contact ROBERT S FREEMAN
Correspondent
W.R. Grace & Co.-Conn.
55 Hayden Ave.
Lexington,  MA  02173
Correspondent Contact ROBERT S FREEMAN
Regulation Number880.5240
Classification Product Code
KGX  
Date Received03/04/1986
Decision Date 03/24/1986
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
Predetermined Change
Control Plan Authorized		 No
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