FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
FDA 510(k) clearance K980930 · decided 1998-09-22
Clearance details
- K-number
- K980930
- Device name
- FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
- Applicant
- Fibra Sonics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-03-12
- Decision date
- 1998-09-22
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.