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 |