SITZMARKS
System, Gastrointestinal Motility (electrical)
Konsyl Pharmaceuticals
The following data is part of a premarket notification filed by Konsyl Pharmaceuticals with the FDA for Sitzmarks.
Pre-market Notification Details
| Device ID | K181750 |
| 510k Number | K181750 |
| Device Name: | SITZMARKS |
| Classification | System, Gastrointestinal Motility (electrical) |
| Applicant | Konsyl Pharmaceuticals 050 Industrial Park Road Easton, MD 21601 |
| Contact | Frank Gunsallus Iii |
| Correspondent | Stuart Portnoy Prism Medical Device Consulting 5151 10th Rd N Arlington, VA 22205 |
| Product Code | FFX |
| CFR Regulation Number | 876.1725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-02 |
| Decision Date | 2018-11-15 |
Trademark Results [SITZMARKS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SITZMARKS 73695673 1492888 Live/Registered |
LAFAYETTE PHARMACAL, INC. 1987-11-16 |
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