MODEL 2000 MILD INTERMITTENT SUCTION PUMP
FDA 510(k) clearance K941526 · decided 1994-05-18
Clearance details
- K-number
- K941526
- Device name
- MODEL 2000 MILD INTERMITTENT SUCTION PUMP
- Applicant
- Product & Educational Services
- Decision
- Substantially Equivalent
- Date received
- 1994-03-30
- Decision date
- 1994-05-18
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- JCX
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Dolestown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.