The following data is part of a premarket notification filed by Smartdata Suzhou Co., Ltd with the FDA for Endorate Valve Sets.
| Device ID | K181509 |
| 510k Number | K181509 |
| Device Name: | Endorate Valve Sets |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | Smartdata Suzhou Co., Ltd 4f, Block 7, 198#, Jinshan Rd Suzhou, CN 215011 |
| Contact | Cindy Ye |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-06-08 |
| Decision Date | 2018-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817658021666 | K181509 | 000 |