FDA 510(k) Application Details - K961036

Device Classification Name Endoilluminator

  More FDA Info for this Device
510(K) Number K961036
Device Name Endoilluminator
Applicant M.B. INDUSTRIES, INC.
1707 MADISON AVE.
GRANITE CITY, IL 62040 US
Other 510(k) Applications for this Company
Contact WAYNE C MOSHER
Other 510(k) Applications for this Contact
Regulation Number 876.1500

  More FDA Info for this Regulation Number
Classification Product Code MPA
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 03/14/1996
Decision Date 07/15/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee OP - Ophthalmic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact