The following data is part of a premarket notification filed by Allergan, Inc. with the FDA for Bks-1000 Refractive Set Use In Keratorefractive.
| Device ID | K870807 |
| 510k Number | K870807 |
| Device Name: | BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE |
| Classification | Keratome, Ac-powered |
| Applicant | ALLERGAN, INC. POST OFFICE BOX 25155 Santa Ana, CA 92799 |
| Contact | Paul S Kramsky |
| Correspondent | Paul S Kramsky ALLERGAN, INC. POST OFFICE BOX 25155 Santa Ana, CA 92799 |
| Product Code | HNO |
| CFR Regulation Number | 886.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-27 |
| Decision Date | 1987-05-29 |