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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name scalpel, one-piece
510(k) Number K863213
Device Name KEISEI SCALPEL (STERILE AND NON-STERILE)
Applicant
KEISEI MEDICAL INDUSTRIAL CO., LTD.
9 AUTUMN DR.
BETHEL,  CT  06801
Applicant Contact DEBORAH A KUTER
Correspondent
KEISEI MEDICAL INDUSTRIAL CO., LTD.
9 AUTUMN DR.
BETHEL,  CT  06801
Correspondent Contact DEBORAH A KUTER
Regulation Number878.4800
Classification Product Code
GDX  
Date Received08/20/1986
Decision Date 09/02/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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