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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handle, Scalpel
510(k) Number K852042
Device Name BRIMFIELD CANNULATED BLADE HOLDER
Applicant
Brimfield Scientific Instruments
Mill Ln. Rd.
Brimfield,  MA  01010
Applicant Contact DAVID W ANTONOPOULO
Correspondent
Brimfield Scientific Instruments
Mill Ln. Rd.
Brimfield,  MA  01010
Correspondent Contact DAVID W ANTONOPOULO
Regulation Number878.4800
Classification Product Code
GDZ  
Date Received05/09/1985
Decision Date 06/11/1985
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
Predetermined Change
Control Plan Authorized		 No
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