FDA 510(k) Application Details - K973068

Device Classification Name Laparoscope, General & Plastic Surgery

  More FDA Info for this Device
510(K) Number K973068
Device Name Laparoscope, General & Plastic Surgery
Applicant KARL STORZ ENDOSKOP GMBH
600 CORPORATE POINTE
CULVER CITY, CA 90230 US
Other 510(k) Applications for this Company
Contact KEVIN KENNAN
Other 510(k) Applications for this Contact
Regulation Number 876.1500

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

  More FDA Info for this Product Code
Date Received 08/18/1997
Decision Date 11/07/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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