GRIESHABER SCLERAL BUCKLING BALLOON CATHETER
FDA premarket approval P930024 · decided 1994-06-02
Approval details
- PMA number
- P930024
- Trade name
- GRIESHABER SCLERAL BUCKLING BALLOON CATHETER
- Generic name
- Catheter, balloon for retinal reattachment
- Applicant
- Labtician Ophthalmics, Inc.
- Date received
- 1992-03-16
- Decision date
- 1994-06-02
- Days to decision
- 808 days
- Decision code
- APWD
- Product code
- LOG
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Oakville, Ontario
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 (K000544) | Labtician Ophthalmics, Inc. | 2000-03-09 |
| LABTICIAN LID LOAD EXTERNAL EYELID SIZING SET (K990224) | Labtician Ophthalmics, Inc. | 1999-04-12 |
| LABTICIAN LID LOAD GOLD EYELID WEIGHT IMPLANTS (K983607) | Labtician Ophthalmics, Inc. | 1999-01-08 |