Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Snare, Flexible
510(k) Number K150316
Device Name Polypectomy Snare
Applicant
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd.
Nanjing,  CN 210032
Applicant Contact BECKY LI
Correspondent
Micro-Tech (Nanjing) Co., Ltd.
# 10 Gaoke Third Rd.
Nanjing,  CN 210032
Correspondent Contact BECKY LI
Regulation Number876.4300
Classification Product Code
FDI  
Date Received02/09/2015
Decision Date 07/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-