INSTRUMENT IRRIGATION PUMP
FDA 510(k) clearance K921253 · decided 1992-08-06
Clearance details
- K-number
- K921253
- Device name
- INSTRUMENT IRRIGATION PUMP
- Applicant
- Psi Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-03-16
- Decision date
- 1992-08-06
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- KOD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Norwalk, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.