OCCLUFAST
FDA 510(k) clearance K935889 · decided 1994-08-23
Clearance details
- K-number
- K935889
- Device name
- OCCLUFAST
- Applicant
- Zhermack Dental Production
- Decision
- Substantially Equivalent
- Date received
- 1993-10-12
- Decision date
- 1994-08-23
- Days to decision
- 315 days
- Clearance type
- Traditional
- Product code
- ELW
- Device class
- 2
- Regulation number
- 872.3660
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- (Rovigo) Italy, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.