The following data is part of a premarket notification filed by Z-medica, Llc with the FDA for Quikclot Control+.
| Device ID | K200167 | 
| 510k Number | K200167 | 
| Device Name: | QuikClot Control+ | 
| Classification | Temporary, Internal Use Hemostatic | 
| Applicant | Z-Medica, LLC 4 Fairfield Boulevard Wallingford, CT 06492 | 
| Contact | Soraya King | 
| Correspondent | Soraya King Z-Medica, LLC 4 Fairfield Boulevard Wallingford, CT 06492 | 
| Product Code | POD | 
| CFR Regulation Number | 878.4454 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 2020-01-23 | 
| Decision Date | 2020-04-23 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  QUIKCLOT CONTROL+  86913152  5375870 Live/Registered | Z-MEDICA, LLC 2016-02-19 |