INSPEKTOR PRO
FDA 510(k) clearance K040063 · decided 2004-06-24
Clearance details
- K-number
- K040063
- Device name
- INSPEKTOR PRO
- Applicant
- Inspektor Dental Care BV
- Decision
- Substantially Equivalent
- Date received
- 2004-01-13
- Decision date
- 2004-06-24
- Days to decision
- 163 days
- Clearance type
- Traditional
- Product code
- NBL
- Device class
- 2
- Regulation number
- 872.1745
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Amsterdam, NL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.