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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, disposable
510(k) Number K864139
Device Name RANFAC CUT BIOPSY NEEDLE
Applicant
RANFAC CORP.
30 DOHERTY AVE., P.O. BOX 635
AVON INDUSTRIAL PARK
AVON,  MA  02322
Applicant Contact DENNIS E FOWLER
Correspondent
RANFAC CORP.
30 DOHERTY AVE., P.O. BOX 635
AVON INDUSTRIAL PARK
AVON,  MA  02322
Correspondent Contact DENNIS E FOWLER
Regulation Number878.4800
Classification Product Code
GAA  
Date Received10/22/1986
Decision Date 11/05/1986
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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