PCXX VARNISH
FDA 510(k) clearance K113146 · decided 2012-01-23
Clearance details
- K-number
- K113146
- Device name
- PCXX VARNISH
- Applicant
- Ross Healthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-10-24
- Decision date
- 2012-01-23
- Days to decision
- 91 days
- Clearance type
- Abbreviated
- Product code
- LBH
- Device class
- 2
- Regulation number
- 872.3260
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Blaine, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.