The following data is part of a premarket notification filed by Innovasis, Inc. with the FDA for Truview Light Cable, Truview Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End.
| Device ID | K200874 |
| 510k Number | K200874 |
| Device Name: | TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 |
| Contact | Marshall Mccarty |
| Correspondent | Marshall Mccarty Innovasis, Inc. 614 East 3900 South Salt Lake City, UT 84107 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-01 |
| Decision Date | 2020-06-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M711LS5530 | K200874 | 000 |