The following data is part of a premarket notification filed by Pro-optics, Inc. with the FDA for Optik-aids/optic-shop Thermal/therma Pro Lens Case.
| Device ID | K875197 |
| 510k Number | K875197 |
| Device Name: | OPTIK-AIDS/OPTIC-SHOP THERMAL/THERMA PRO LENS CASE |
| Classification | Case, Contact Lens |
| Applicant | PRO-OPTICS, INC. C/O HOOGENDOORN TALBOT, DAVIDS 122 S. MICHIGAN AVENUE Chicago, IL 60603 |
| Contact | James Davids |
| Correspondent | James Davids PRO-OPTICS, INC. C/O HOOGENDOORN TALBOT, DAVIDS 122 S. MICHIGAN AVENUE Chicago, IL 60603 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-17 |
| Decision Date | 1988-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00725439991513 | K875197 | 000 |
| 00725439991506 | K875197 | 000 |
| 00075063225127 | K875197 | 000 |
| 30075063122502 | K875197 | 000 |
| 00075063112502 | K875197 | 000 |
| 20075063012509 | K875197 | 000 |
| 00713733546867 | K875197 | 000 |
| 00713733546850 | K875197 | 000 |
| 00760236290513 | K875197 | 000 |