FDA 510(k) Application Details - K160625

Device Classification Name Forceps, Biopsy, Electric

  More FDA Info for this Device
510(K) Number K160625
Device Name Forceps, Biopsy, Electric
Applicant MICRO-TECH (NANJING) CO., LTD.
NO. 10 GAOKE THIRD ROAD
NANJING 210032 CN
Other 510(k) Applications for this Company
Contact BECKY LI
Other 510(k) Applications for this Contact
Regulation Number 876.4300

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

  More FDA Info for this Product Code
Date Received 03/04/2016
Decision Date 06/14/2016
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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