PREMIE U-BAG URINE SPECIMEN COLLECTOR
FDA 510(k) clearance K950176 · decided 1995-02-07
Clearance details
- K-number
- K950176
- Device name
- PREMIE U-BAG URINE SPECIMEN COLLECTOR
- Applicant
- Hollister, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-17
- Decision date
- 1995-02-07
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- FOC
- Device class
- 2
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Libertyville, IL, 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 |
|---|---|---|
| RIMECO MIDSTREAM URINE COLLECTOR (K943752) | Rimeco Products, Inc. | 1994-11-01 |
| BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE (K911329) | C.R. Bard, Inc. | 1991-05-28 |
| PORTABLE INFANT VENTILATOR (K771368) | Cavitron Corp. | 1977-08-04 |
Recalls involving this device
No recalls on record reference this clearance.