EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA
FDA 510(k) clearance K853094 · decided 1986-04-04
Clearance details
- K-number
- K853094
- Device name
- EMPEROR 5/20 & STD, C.C, ORTHO, PSP REFIT, PERISEA
- Applicant
- Psp Dental Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1985-07-23
- Decision date
- 1986-04-04
- Days to decision
- 255 days
- Clearance type
- Traditional
- Product code
- EBI
- Device class
- 2
- Regulation number
- 872.3760
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Belvedere, Kent, GB
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.