The following data is part of a premarket notification filed by Bruce A. Berkley with the FDA for Dateminder Contact Lens Case.
Device ID | K945259 |
510k Number | K945259 |
Device Name: | DATEMINDER CONTACT LENS CASE |
Classification | Case, Contact Lens |
Applicant | BRUCE A. BERKLEY 410 DELAWARE ST. Downs, KS 67437 |
Contact | Bruce A Berkley |
Correspondent | Bruce A Berkley BRUCE A. BERKLEY 410 DELAWARE ST. Downs, KS 67437 |
Product Code | LRX |
CFR Regulation Number | 886.5928 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-10-28 |
Decision Date | 1995-01-24 |