SimplCath
Catheter, Urethral
F&S Medical Solutions, LLC
The following data is part of a premarket notification filed by F&s Medical Solutions, Llc with the FDA for Simplcath.
Pre-market Notification Details
| Device ID | K182511 |
| 510k Number | K182511 |
| Device Name: | SimplCath |
| Classification | Catheter, Urethral |
| Applicant | F&S Medical Solutions, LLC 10221 Woodridge Lane Omaha, NE 68124 |
| Contact | Sonia M. Rocha-sanchez |
| Correspondent | Tom Renner Vision28 915 SW Rimrock Way STE 201 PMB 402 Redmond, OR 97756 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-12 |
| Decision Date | 2019-03-20 |
Trademark Results [SimplCath]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SIMPLCATH 87658857 not registered Live/Pending |
F&S Medical Solutions, LLC 2017-10-25 |
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