The following data is part of a premarket notification filed by Minimally Invasive Devices Llc with the FDA for Defogging And Cleaning Solution- Flo-x.
| Device ID | K102452 |
| 510k Number | K102452 |
| Device Name: | DEFOGGING AND CLEANING SOLUTION- FLO-X |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | MINIMALLY INVASIVE DEVICES LLC 6329 SW 81ST ROAD Lake Butler, FL 32054 |
| Contact | Mark L Friedman, Ph.d |
| Correspondent | Mark L Friedman, Ph.d MINIMALLY INVASIVE DEVICES LLC 6329 SW 81ST ROAD Lake Butler, FL 32054 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-27 |
| Decision Date | 2010-12-23 |
| Summary: | summary |