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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 K202287
Device Name Ran-Flex-B Bone Marrow Aspiration Needle
Applicant
Ranfac Corporation
30 Doherty St.
Avon,  MA  02322
Applicant Contact Eric Kreuz
Correspondent
Ranfac Corporation
30 Doherty St.
Avon,  MA  02322
Correspondent Contact Eric Kreuz
Regulation Number876.1075
Classification Product Code
KNW  
Date Received08/12/2020
Decision Date 09/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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