The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Automatic Lensometer.
Device ID | K936199 |
510k Number | K936199 |
Device Name: | AUTOMATIC LENSOMETER |
Classification | Instrument, Measuring, Lens, Ac-powered |
Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Contact | Koichi Yano |
Correspondent | Koichi Yano CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
Product Code | HLM |
CFR Regulation Number | 886.1425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-12-29 |
Decision Date | 1994-09-28 |