The following data is part of a premarket notification filed by Ga Health Company Limited with the FDA for Vacutore Air/water Bottle Tubing, Vacutore Co2 Tubing With Luer Connector.
| Device ID | K200388 |
| 510k Number | K200388 |
| Device Name: | Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing With Luer Connector |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | GA Health Company Limited Unit 18, 21/F, Metropole Square, 2 On Yiu Street, Shatin Hong Kong, CN |
| Contact | Cindy Ye |
| Correspondent | Rafael Aguila Accelerated Device Approval Services, LLC 6800 S.W. 40th Street, Ste. 444 Ludlum, FL 33155 -3708 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2020-02-18 |
| Decision Date | 2020-04-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14897106954978 | K200388 | 000 |
| 14897106950123 | K200388 | 000 |
| 14897106950147 | K200388 | 000 |
| 04897106950164 | K200388 | 000 |
| 14897106950185 | K200388 | 000 |
| 14897106950192 | K200388 | 000 |
| 14897106950208 | K200388 | 000 |
| 14897106953797 | K200388 | 000 |
| 14897106954954 | K200388 | 000 |
| 14897106950086 | K200388 | 000 |