The following data is part of a premarket notification filed by Smartdata Suzhou Co., Ltd with the FDA for Vacutore Air/water Bottle Tubing.
| Device ID | K191366 |
| 510k Number | K191366 |
| Device Name: | Vacutore Air/Water Bottle Tubing |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | Smartdata Suzhou Co., Ltd 4f, Block 7, 198#, Jinshan Rd Suzhou, CN 215011 |
| Contact | Cindy Ye |
| Correspondent | Thomas Schorre 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 | 2019-05-22 |
| Decision Date | 2019-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00849771041344 | K191366 | 000 |