The following data is part of a premarket notification filed by Labtician Ophthalmics, Inc. with the FDA for Boucher Degroot Head Positioning Glasses, Model 8080.
| Device ID | K000544 |
| 510k Number | K000544 |
| Device Name: | BOUCHER DEGROOT HEAD POSITIONING GLASSES, MODEL 8080 |
| Classification | Reader, Prism, Ophthalmic |
| Applicant | LABTICIAN OPHTHALMICS, INC. 2140 WINSTON PARK DR., UNIT 6 Oakville, Ontario, CA L6h 5v5 |
| Contact | R. David Sculati |
| Correspondent | R. David Sculati LABTICIAN OPHTHALMICS, INC. 2140 WINSTON PARK DR., UNIT 6 Oakville, Ontario, CA L6h 5v5 |
| Product Code | HJX |
| CFR Regulation Number | 886.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-18 |
| Decision Date | 2000-03-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00871321002949 | K000544 | 000 |