FDA 510(k) Application Details - K971842

Device Classification Name	Kit, Needle, Biopsy   More FDA Info for this Device
510(K) Number	K971842
Device Name	Kit, Needle, Biopsy
Applicant	UNITED STATES ENDOSCOPY GROUP, INC. 9330 PROGRESS PKWY. MENTOR, OH 44060 US Other 510(k) Applications for this Company
Contact	GRETCHEN Y COHEN Other 510(k) Applications for this Contact
Regulation Number	876.1075   More FDA Info for this Regulation Number
Classification Product Code	FCG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/19/1997
Decision Date	06/20/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review