The following data is part of a premarket notification filed by Coag Medical Llc with the FDA for Stopsbleeding Topical Hemostat Powder And Foam.
| Device ID | K140313 |
| 510k Number | K140313 |
| Device Name: | STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM |
| Classification | Dressing, Wound, Drug |
| Applicant | COAG MEDICAL LLC 4486 TIMBERLINE CT. Vadnais Heights, MN 55127 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath COAG MEDICAL LLC 4486 TIMBERLINE CT. Vadnais Heights, MN 55127 |
| 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 | 2014-02-10 |
| Decision Date | 2014-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850817006494 | K140313 | 000 |
| 00850817006067 | K140313 | 000 |
| 00850817006111 | K140313 | 000 |
| 00850817006135 | K140313 | 000 |
| 00850817006142 | K140313 | 000 |
| 00850817006159 | K140313 | 000 |
| 00850817006197 | K140313 | 000 |
| 00850817006210 | K140313 | 000 |
| 00850817006227 | K140313 | 000 |
| 00850817006234 | K140313 | 000 |
| 00850817006241 | K140313 | 000 |
| 00850817006258 | K140313 | 000 |
| 00850817006265 | K140313 | 000 |
| 00850817006326 | K140313 | 000 |
| 00850817006456 | K140313 | 000 |
| 00850817006463 | K140313 | 000 |
| 00850817006470 | K140313 | 000 |
| 00850817006005 | K140313 | 000 |