VELOPEX AQUACUT FLUID ABRASION UNIT
FDA 510(k) clearance K024105 · decided 2003-10-09
Clearance details
- K-number
- K024105
- Device name
- VELOPEX AQUACUT FLUID ABRASION UNIT
- Applicant
- Velopex International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-12-13
- Decision date
- 2003-10-09
- Days to decision
- 300 days
- Clearance type
- Traditional
- Product code
- KOJ
- Device class
- 2
- Regulation number
- 872.6080
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- St. Cloud, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.