FDA 510(k) Application Details - K970961

Device Classification Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)

  More FDA Info for this Device
510(K) Number K970961
Device Name Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
Applicant RICHARD WOLF MEDICAL INSTRUMENTS CORP.
353 CORPORATE WOODS PKWY.
VERNON HILLS, IL 60061 US
Other 510(k) Applications for this Company
Contact ROBERT L CASARSA
Other 510(k) Applications for this Contact
Regulation Number 884.4160

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

  More FDA Info for this Product Code
Date Received 03/17/1997
Decision Date 04/10/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee OB - Obstetrics/Gynecology
Review Advisory Committee OB - Obstetrics/Gynecology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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