ALLIGER ULTRASONIC SURGICAL SYSTEM
FDA 510(k) clearance K933559 · decided 1993-10-15
Clearance details
- K-number
- K933559
- Device name
- ALLIGER ULTRASONIC SURGICAL SYSTEM
- Applicant
- Medsonic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-07-22
- Decision date
- 1993-10-15
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Farmingdale, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LySonix 2000 Ultrasonic Surgical Systems, MODEL NO. LY-2000. --- Old labeling: MANUFACTURE recall (Z-0070-04) | Misonix, Inc | 2003-10-30 |