FDA 510(k) Application Details - K170899

Device Classification Name Laparoscope, General & Plastic Surgery

  More FDA Info for this Device
510(K) Number K170899
Device Name Laparoscope, General & Plastic Surgery
Applicant LG Electronics
222, LG-ro, Cheongho-ri, Jinwi-myeon
Pyeongtaek-si 17709 KR
Other 510(k) Applications for this Company
Contact Jinhwan Jun
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 03/27/2017
Decision Date 05/30/2017
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