SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR
FDA 510(k) clearance K913848 · decided 1992-03-27
Clearance details
- K-number
- K913848
- Device name
- SHARPLAN MODEL ULTRA ULTRASONIC SURG ASPIRATOR
- Applicant
- Sharplan Lasers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-27
- Decision date
- 1992-03-27
- Days to decision
- 213 days
- Clearance type
- Traditional
- Product code
- MGI
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Allendale, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.