FDA 510(k) Application Details - K990731

Device Classification Name Laparoscope, General & Plastic Surgery

  More FDA Info for this Device
510(K) Number K990731
Device Name Laparoscope, General & Plastic Surgery
Applicant EASTGATE TRADING CORP.
990 AVE. OF AMERICAS, #15D
NEW YORK, NY 10084 US
Other 510(k) Applications for this Company
Contact MORRIS CORN
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 03/05/1999
Decision Date 05/19/1999
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