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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name guide, needle, surgical
510(k) Number K845038
Device Name BREAST & FOREIGN BODY LOCALIZATION INSTRUMENT
Applicant
RANFAC CORP.
30 DOHERTY AVE., P.O. BOX 635
AVON INDUSTRIAL PARK
AVON,  MA  02322
Applicant Contact MICHAEL P CODY
Correspondent
RANFAC CORP.
30 DOHERTY AVE., P.O. BOX 635
AVON INDUSTRIAL PARK
AVON,  MA  02322
Correspondent Contact MICHAEL P CODY
Regulation Number878.4800
Classification Product Code
GDF  
Date Received12/27/1984
Decision Date 03/11/1985
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
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