Ran-Flex-B Bone Marrow Aspiration Needle

Instrument, Biopsy

Ranfac Corporation

The following data is part of a premarket notification filed by Ranfac Corporation with the FDA for Ran-flex-b Bone Marrow Aspiration Needle.

Pre-market Notification Details

Device IDK202287
510k NumberK202287
Device Name:Ran-Flex-B Bone Marrow Aspiration Needle
ClassificationInstrument, Biopsy
Applicant Ranfac Corporation 30 Doherty Street Avon,  MA  02322
ContactEric Kreuz
CorrespondentEric Kreuz
Ranfac Corporation 30 Doherty Street Avon,  MA  02322
Product CodeKNW  
CFR Regulation Number876.1075 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-12
Decision Date2020-09-18

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