LYNX-SM, SCLAER DENTAL HANDPIECE
FDA 510(k) clearance K901488 · decided 1990-05-15
Clearance details
- K-number
- K901488
- Device name
- LYNX-SM, SCLAER DENTAL HANDPIECE
- Applicant
- Mti Precision Products
- Decision
- Substantially Equivalent
- Date received
- 1990-03-29
- Decision date
- 1990-05-15
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- ELC
- Device class
- 2
- Regulation number
- 872.4850
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lakewood, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.