The following data is part of a premarket notification filed by Lkc Technologies, Inc. with the FDA for Anomaloscope Quadrant Test-6.
Device ID | K913962 |
510k Number | K913962 |
Device Name: | ANOMALOSCOPE QUADRANT TEST-6 |
Classification | Anomaloscope |
Applicant | LKC TECHNOLOGIES, INC. 2 PROFESSIONAL DR., SUITE 222 Gaithersburg, MD 20879 |
Contact | Jerome Leight |
Correspondent | Jerome Leight LKC TECHNOLOGIES, INC. 2 PROFESSIONAL DR., SUITE 222 Gaithersburg, MD 20879 |
Product Code | HIW |
CFR Regulation Number | 886.1070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-09-05 |
Decision Date | 1991-10-23 |