WATERS ILEAL RESERVOIR CATHETER
FDA 510(k) clearance K813494 · decided 1981-12-31
Clearance details
- K-number
- K813494
- Device name
- WATERS ILEAL RESERVOIR CATHETER
- Applicant
- Waters Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-12-14
- Decision date
- 1981-12-31
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- KPH
- Device class
- 1
- Regulation number
- 876.5030
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.