HAND-HELD IRRIGATION PUMP
FDA 510(k) clearance K933757 · decided 1994-08-26
Clearance details
- K-number
- K933757
- Device name
- HAND-HELD IRRIGATION PUMP
- Applicant
- Ximed Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 1993-07-14
- Decision date
- 1994-08-26
- Days to decision
- 408 days
- Clearance type
- Traditional
- Product code
- BTA
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.