The following data is part of a premarket notification filed by Lacrimedics, Inc. with the FDA for Focometer.
Device ID | K944402 |
510k Number | K944402 |
Device Name: | FOCOMETER |
Classification | Ophthalmoscope, Battery-powered |
Applicant | LACRIMEDICS, INC. 190 N. ARROWHEAD AVE, STE B Rialto, CA 92376 |
Contact | Robert S Herrick Ii |
Correspondent | Robert S Herrick Ii LACRIMEDICS, INC. 190 N. ARROWHEAD AVE, STE B Rialto, CA 92376 |
Product Code | HLJ |
CFR Regulation Number | 886.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-12 |
Decision Date | 1994-11-22 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FOCOMETER 74558881 2008929 Dead/Cancelled |
INFOCUS 1994-08-09 |