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FDA 510(k) Application Details - K223612
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K223612
Device Name
Instrument, Biopsy
Applicant
Ranfac Corporation
30 Doherty Avenue
Avon, MA 02322 US
Other 510(k) Applications for this Company
Contact
Eric Kreuz
Other 510(k) Applications for this Contact
Regulation Number
876.1075
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Classification Product Code
KNW
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More FDA Info for this Product Code
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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