The following data is part of a premarket notification filed by Star Mountain Medical, Inc. with the FDA for Capklenz.
| Device ID | K192382 |
| 510k Number | K192382 |
| Device Name: | CapKlenZ |
| Classification | Cap, Device Disinfectant |
| Applicant | Star Mountain Medical, Inc. 9005 Montana Ave, Suite A El Paso, TX 79925 |
| Contact | Aaron Chiu |
| Correspondent | E. J. Smith Smith Associates 1468 Harwell Ave. Crofton, MD 21114 |
| Product Code | QBP |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-30 |
| Decision Date | 2020-04-20 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CAPKLENZ 87362212 5436368 Live/Registered |
Turnstone Technologies, LLC 2017-03-07 |