RINOFLOW MICRONIZED E.N.T. WASH SYSTEM
FDA 510(k) clearance K973875 · decided 1998-01-26
Clearance details
- K-number
- K973875
- Device name
- RINOFLOW MICRONIZED E.N.T. WASH SYSTEM
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-10-10
- Decision date
- 1998-01-26
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- KMA
- Device class
- 1
- Regulation number
- 874.5550
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NAVAGE NASAL IRRIGATOR, NAVAGE NOSE CLEANER (K140542) | Rhinosystems, Inc. | 2014-06-27 |
| RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM (K963550) | Respironics, Inc. | 1996-11-01 |
| MICROFLOW IRRIGATION SYSTEM (K950078) | Jedmed Instrument Co. | 1995-06-21 |
| POWDER BLOWERS (K822351) | Kelleher Corp. | 1982-09-14 |
Recalls involving this device
No recalls on record reference this clearance.