CMI E-Z FLO BULB P.N. 701
FDA 510(k) clearance K932128 · decided 1994-04-07
Clearance details
- K-number
- K932128
- Device name
- CMI E-Z FLO BULB P.N. 701
- Applicant
- Columbia Medical & Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-05-03
- Decision date
- 1994-04-07
- Days to decision
- 339 days
- Clearance type
- Traditional
- Product code
- FFY
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Bend, OR, 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 |
|---|---|---|
| WORKING CHANNEL VALVE (K900781) | Applied Urology, Inc. | 1990-04-25 |
Recalls involving this device
No recalls on record reference this clearance.