FDA 510(k) Application Details - K223612

Device Classification Name Instrument, Biopsy

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510(K) Number K223612
Device Name Instrument, Biopsy
Applicant Ranfac Corporation
30 Doherty Avenue
Avon, MA 02322 US
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Contact Eric Kreuz
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 12/05/2022
Decision Date 02/21/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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