FDA 510(k) Application Details - K972119

Device Classification Name	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology   More FDA Info for this Device
510(K) Number	K972119
Device Name	Bougie, Esophageal, And Gastrointestinal, Gastro-Urology
Applicant	MEDOVATIONS, INC. W194 N11340 MCCORMICK DR. GERMANTOWN, WI 53022 US Other 510(k) Applications for this Company
Contact	CHARLES G STANFORD Other 510(k) Applications for this Contact
Regulation Number	876.5365   More FDA Info for this Regulation Number
Classification Product Code	FAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/05/1997
Decision Date	02/02/1998
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