SONOTOME ULTRASONIC ASPIRATOR TIPS
FDA 510(k) clearance K010637 · decided 2001-04-20
Clearance details
- K-number
- K010637
- Device name
- SONOTOME ULTRASONIC ASPIRATOR TIPS
- Applicant
- Synergetics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-05
- Decision date
- 2001-04-20
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- St. Charles, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.