The following data is part of a premarket notification filed by Remedium Technologies, Inc. with the FDA for Hemogrip Patch.
| Device ID | K143466 |
| 510k Number | K143466 |
| Device Name: | Hemogrip Patch |
| Classification | Dressing, Wound, Drug |
| Applicant | REMEDIUM TECHNOLOGIES, INC. 387 TECHNOLOGY DR. SUITE 3110B College Park, MD 20742 |
| Contact | John Gustin |
| Correspondent | John Gustin REMEDIUM TECHNOLOGIES, INC. 387 TECHNOLOGY DR. SUITE 3110B College Park, MD 20742 |
| Product Code | FRO |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-04 |
| Decision Date | 2015-06-08 |
| Summary: | summary |