FDA 510(k) Application Details - K203397

Device Classification Name	Instrument, Biopsy   More FDA Info for this Device
510(K) Number	K203397
Device Name	Instrument, Biopsy
Applicant	Biopsybell s.r.l. Via A. Manuzio, 24 Mirandola 41037 IT Other 510(k) Applications for this Company
Contact	Carlo Ricca Prandi Bellini Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	KNW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/18/2020
Decision Date	01/11/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review