RIMECO MIDSTREAM URINE COLLECTOR
FDA 510(k) clearance K943752 · decided 1994-11-01
Clearance details
- K-number
- K943752
- Device name
- RIMECO MIDSTREAM URINE COLLECTOR
- Applicant
- Rimeco Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-02
- Decision date
- 1994-11-01
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- FOC
- Device class
- 2
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Oakwood Village, OH, 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 |
|---|---|---|
| PREMIE U-BAG URINE SPECIMEN COLLECTOR (K950176) | Hollister, Inc. | 1995-02-07 |
| 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.