SAFESEAL REUSABLE URINAL SYSTEM
FDA 510(k) clearance K851682 · decided 1985-06-24
Clearance details
- K-number
- K851682
- Device name
- SAFESEAL REUSABLE URINAL SYSTEM
- Applicant
- Dbt Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1985-04-23
- Decision date
- 1985-06-24
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- EXJ
- Device class
- 1
- Regulation number
- 876.5250
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Witney,0x8 7az, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.