VARNISHAMERICA
FDA 510(k) clearance K040098 · decided 2004-02-04
Clearance details
- K-number
- K040098
- Device name
- VARNISHAMERICA
- Applicant
- Medical Products Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-20
- Decision date
- 2004-02-04
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Philadelphia, PA, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.