UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
FDA 510(k) clearance K971992 · decided 1997-08-01
Clearance details
- K-number
- K971992
- Device name
- UROMED ALTERNATIVE BLADDER CONTROL CONTINENCE DEVICE(ABCPN-0026)
- Applicant
- Uromed Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-29
- Decision date
- 1997-08-01
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- FHA
- Device class
- 1
- Regulation number
- 876.5160
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Needham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| RELIANCE URINARY CONTROL INSERT & SIZING DEVICE (P960020/S001) | Uromed Corp. | 1999-04-01 |
| RELIANCE URINARY CONTROL INSERT AND SIZING DEVICE (P960020) | Uromed Corp. | 1996-08-16 |