The following data is part of a premarket notification filed by Hedgepath, Llc with the FDA for Sinuflush Lavage System.
| Device ID | K131177 |
| 510k Number | K131177 |
| Device Name: | SINUFLUSH LAVAGE SYSTEM |
| Classification | Irrigator, Sinus |
| Applicant | HEDGEPATH, LLC 324 S. HYDE PARK AVE. SUITE 350 Tampa, FL 33606 |
| Contact | Frank E O'donnell, Jr Md. |
| Correspondent | Frank E O'donnell, Jr Md. HEDGEPATH, LLC 324 S. HYDE PARK AVE. SUITE 350 Tampa, FL 33606 |
| Product Code | KAR |
| CFR Regulation Number | 874.4420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-25 |
| Decision Date | 2013-09-20 |
| Summary: | summary |