BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
FDA 510(k) clearance K000544 · decided 2000-03-09
Clearance details
- K-number
- K000544
- Device name
- BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080
- Applicant
- Labtician Ophthalmics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-02-18
- Decision date
- 2000-03-09
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- HJX
- Device class
- 1
- Regulation number
- 886.5810
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Oakville, Ontario, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GRIESHABER SCLERAL BUCKLING BALLOON CATHETER (P930024) | Labtician Ophthalmics, Inc. | 1994-06-02 |