MICROFLOW IRRIGATION SYSTEM
FDA 510(k) clearance K950078 · decided 1995-06-21
Clearance details
- K-number
- K950078
- Device name
- MICROFLOW IRRIGATION SYSTEM
- Applicant
- Jedmed Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-10
- Decision date
- 1995-06-21
- Days to decision
- 162 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
- St.Louis, MO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Jedmed Instrument Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 SYSTEM (K973875) | Respironics, Inc. | 1998-01-26 |
| RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM (K963550) | Respironics, Inc. | 1996-11-01 |
| POWDER BLOWERS (K822351) | Kelleher Corp. | 1982-09-14 |
Recalls involving this device
No recalls on record reference this clearance.