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 Endoscopic Irrigation/Suction System
510(k) Number K200388
Device Name Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector
Applicant
Ga Health Company Limited
Unit 18, 21/F, Metropole Sq., 2 On Yiu St., Shatin
Hong Kong,  CN
Applicant Contact Cindy Ye
Correspondent
Accelerated Device Approval Services
6800 SW 40th St., Suite 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number876.1500
Classification Product Code
OCX  
Subsequent Product Code
FCX  
Date Received02/18/2020
Decision Date 04/14/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-