FDA 510(k) Application Details - K970382

Device Classification Name	Sigmoidoscope And Accessories, Flexible/Rigid   More FDA Info for this Device
510(K) Number	K970382
Device Name	Sigmoidoscope And Accessories, Flexible/Rigid
Applicant	WELCH ALLYN, INC. 4341 STATE ST. RD. P.O. BOX 220 SKANEATELES FALLS, NY 13153-0220 US Other 510(k) Applications for this Company
Contact	LAWRENCE E MAROCCO Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FAM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/03/1997
Decision Date	04/17/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review