FDA 510(k) Application Details - K993604

Device Classification Name	Anti Fog Solution And Accessories, Endoscopy   More FDA Info for this Device
510(K) Number	K993604
Device Name	Anti Fog Solution And Accessories, Endoscopy
Applicant	MECTRA LABS, INC. HIGHWAY 231 SOUTH, 2 QUALITY WAY BLOOMFIELD, IN 47424 US Other 510(k) Applications for this Company
Contact	CHARLES E ALLGOOD Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	OCT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/1999
Decision Date	03/03/2000
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