The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Surgical Auto Keratometer Sk-1.
| Device ID | K871936 |
| 510k Number | K871936 |
| Device Name: | CANON SURGICAL AUTO KERATOMETER SK-1 |
| Classification | Keratoscope, Ac-powered |
| Applicant | CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
| Contact | Tamada |
| Correspondent | Tamada CANON U.S.A., INC. ONE JERICHO PLAZA Jericho, NY 11753 -1000 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-05-18 |
| Decision Date | 1987-06-19 |