URETEROMAT 4400
FDA 510(k) clearance K915751 · decided 1992-04-24
Clearance details
- K-number
- K915751
- Device name
- URETEROMAT 4400
- Applicant
- F.M. Wiest USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-12-23
- Decision date
- 1992-04-24
- Days to decision
- 123 days
- Clearance type
- Traditional
- Product code
- EZN
- Device class
- 2
- Regulation number
- 876.5470
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Oradell, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.