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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 K131157
Device Name RANFAC BONE MARROW ASPIRATION NEEDLE
Applicant
Ranfac, Corp.
30 Doherty Ave., P.O. Box 635
Avon Industrial Park
Avon,  MA  02322
Applicant Contact CHRISTOPHER P WHELAN
Correspondent
Ranfac, Corp.
30 Doherty Ave., P.O. Box 635
Avon Industrial Park
Avon,  MA  02322
Correspondent Contact CHRISTOPHER P WHELAN
Regulation Number876.1075
Classification Product Code
KNW  
Date Received04/24/2013
Decision Date 10/22/2013
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
Predetermined Change
Control Plan Authorized		 No
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