The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Rinoflow Micronized E.n.t. Wash System.
| Device ID | K973875 |
| 510k Number | K973875 |
| Device Name: | RINOFLOW MICRONIZED E.N.T. WASH SYSTEM |
| Classification | Irrigator, Powered Nasal |
| Applicant | RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Contact | Francis X Dobscha |
| Correspondent | Francis X Dobscha RESPIRONICS, INC. 1001 MURRY RIDGE LN. Murrysville, PA 15668 |
| Product Code | KMA |
| CFR Regulation Number | 874.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-10 |
| Decision Date | 1998-01-26 |
| Summary: | summary |