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 |