The following data is part of a premarket notification filed by C2 Therapeutics, Inc. with the FDA for Boa Endoscopic Valve.
| Device ID | K152140 |
| 510k Number | K152140 |
| Device Name: | Boa Endoscopic Valve |
| Classification | Endoscopic Irrigation/suction System |
| Applicant | C2 THERAPEUTICS, INC. 303 CONVENTION WAY, SUITE 1 Redwood City, CA 94063 |
| Contact | Theresa Brandner-allen |
| Correspondent | Theresa Brandner-allen C2 THERAPEUTICS, INC. 303 CONVENTION WAY, SUITE 1 Redwood City, CA 94063 |
| Product Code | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-03 |
| Decision Date | 2015-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00854924006163 | K152140 | 000 |