The following data is part of a premarket notification filed by Solace Therapeutics, Inc. with the FDA for Vesair 0 Degree Cystoscope, Vesair 30 Degree Long Cystoscope, Vesair 70 Degree Long Cystoscope,vesair 30 Degree Cystoscope,vesair 70 Degree Cystoscope.
| Device ID | K170862 |
| 510k Number | K170862 |
| Device Name: | Vesair 0 Degree Cystoscope, Vesair 30 Degree Long Cystoscope, Vesair 70 Degree Long Cystoscope,Vesair 30 Degree Cystoscope,Vesair 70 Degree Cystoscope |
| Classification | Cystoscope And Accessories, Flexible/rigid |
| Applicant | Solace Therapeutics, Inc. 135 Newbury St Framingham, MA 01701 |
| Contact | Scott Blood |
| Correspondent | Scott Blood Solace Therapeutics 135 Newbury St Framingham, MA 01701 |
| Product Code | FAJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-23 |
| Decision Date | 2017-12-19 |
| Summary: | summary |