The following data is part of a premarket notification filed by Misder, Llc with the FDA for Llics(tm) Laparascopic Lens Internal Cleaning System.
| Device ID | K120821 |
| 510k Number | K120821 |
| Device Name: | LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM |
| Classification | Anti Fog Solution And Accessories, Endoscopy |
| Applicant | MISDER, LLC 433 PARK POINT DRIVE SUITE 140 Golden, CO 80401 |
| Contact | Nancy Sauer |
| Correspondent | Nancy Sauer MISDER, LLC 433 PARK POINT DRIVE SUITE 140 Golden, CO 80401 |
| Product Code | OCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-19 |
| Decision Date | 2012-05-11 |
| Summary: | summary |