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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Biopsy
510(k) Number K031344
Device Name RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE
Applicant
RANFAC CORP.
53 KENNEDY RD.
FOSTER,  RI  02825
Applicant Contact ANNETTE M FAGNANT
Correspondent
RANFAC CORP.
53 KENNEDY RD.
FOSTER,  RI  02825
Correspondent Contact ANNETTE M FAGNANT
Regulation Number876.1075
Classification Product Code
KNW  
Date Received04/29/2003
Decision Date 05/23/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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