The following data is part of a premarket notification filed by Insight Instruments, Inc. with the FDA for Super View Disposable Biom Lens Set.
| Device ID | K051630 |
| 510k Number | K051630 |
| Device Name: | SUPER VIEW DISPOSABLE BIOM LENS SET |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | INSIGHT INSTRUMENTS, INC. 5400 SOUTH BRYANT AVE. Sanford, FL 32773 |
| Contact | Michael Annen |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2005-06-17 |
| Decision Date | 2005-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10856222004176 | K051630 | 000 |
| 10856222004060 | K051630 | 000 |
| 10856222004046 | K051630 | 000 |
| 10856222004039 | K051630 | 000 |
| 00856222004001 | K051630 | 000 |
| 00852475007059 | K051630 | 000 |
| 10852475007209 | K051630 | 000 |