The following data is part of a premarket notification filed by Bausch & Lomb, Inc. with the FDA for Bausch & Lomb Gr-3 Refractor.
| Device ID | K862521 |
| 510k Number | K862521 |
| Device Name: | BAUSCH & LOMB GR-3 REFRACTOR |
| Classification | Refractometer, Ophthalmic |
| Applicant | BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
| Contact | Nicholas A Walp |
| Correspondent | Nicholas A Walp BAUSCH & LOMB, INC. 1400 NORTH GOODMAN ST. P.O.BOX 450 Rochester, NY 14692 |
| Product Code | HKO |
| CFR Regulation Number | 886.1760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-01 |
| Decision Date | 1986-07-11 |