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FDA 510(k) Application Details - K190177
Device Classification Name
Instrument, Biopsy
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510(K) Number
K190177
Device Name
Instrument, Biopsy
Applicant
Ranfac Corporation
30 Doherty Ave
Avon, MA 02322 US
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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
02/01/2019
Decision Date
06/12/2019
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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