GUARDIAN URETHRAL SHEATH
Accessories, Catheter, G-u
SOLACE THERAPEUTICS
The following data is part of a premarket notification filed by Solace Therapeutics with the FDA for Guardian Urethral Sheath.
Pre-market Notification Details
| Device ID | K131803 |
| 510k Number | K131803 |
| Device Name: | GUARDIAN URETHRAL SHEATH |
| Classification | Accessories, Catheter, G-u |
| Applicant | SOLACE THERAPEUTICS 135 NEWBURY ST Framingham, MA 01701 |
| Contact | William Gruber |
| Correspondent | William Gruber SOLACE THERAPEUTICS 135 NEWBURY ST Framingham, MA 01701 |
| Product Code | KNY |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-19 |
| Decision Date | 2013-08-20 |
| Summary: | summary |
Trademark Results [GUARDIAN URETHRAL SHEATH]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GUARDIAN URETHRAL SHEATH 86238493 4624978 Live/Registered |
Solace Therapeutics, Inc. 2014-04-01 |
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