I-MAX TOUCH
FDA 510(k) clearance K083057 · decided 2009-06-02
Clearance details
- K-number
- K083057
- Device name
- I-MAX TOUCH
- Applicant
- Owandy
- Decision
- Substantially Equivalent
- Date received
- 2008-10-14
- Decision date
- 2009-06-02
- Days to decision
- 231 days
- Clearance type
- Traditional
- Product code
- MUH
- Device class
- 2
- Regulation number
- 872.1800
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Ormond Beach, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.