FDA 510(k) Application Details - K953419

Device Classification Name Laparoscope, General & Plastic Surgery

  More FDA Info for this Device
510(K) Number K953419
Device Name Laparoscope, General & Plastic Surgery
Applicant LASER OPTIK SYSTEME GMBH & CO. KG
AM SAGEWERK 11
AMTSGERICHT MAINZ HRB 4527
MAINZ 55124 DE
Other 510(k) Applications for this Company
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 07/03/1995
Decision Date 02/08/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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