UCB
FDA 510(k) clearance K950689 · decided 1995-03-06
Clearance details
- K-number
- K950689
- Device name
- UCB
- Applicant
- Cox Medical Ent., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-02-14
- Decision date
- 1995-03-06
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- MNL
- Device class
- 1
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ventura, CA, 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 |
|---|---|---|
| MILL-ROSE SCOPE CLEANING BRUSH (K946293) | Mill-Rose Laboratory | 1995-02-16 |
| ENDO-SPONGE (K892218) | Endovations | 1989-05-31 |
| CLEANING BRUSH (K874239) | Endovations | 1987-12-29 |
Recalls involving this device
No recalls on record reference this clearance.