The following data is part of a premarket notification filed by Statguard, Llc with the FDA for Statguard Hemostatic Patch, Statguard Hemostatic Dressing.
| Device ID | K172155 |
| 510k Number | K172155 |
| Device Name: | StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing |
| Classification | Dressing, Wound, Drug |
| Applicant | StatGuard, LLC 7555 Cason Lane Gladstone, OR 97027 |
| Contact | Gary Mills |
| Correspondent | Gary Mills StatGuard, LLC 7555 Cason Lane Gladstone, OR 97027 |
| 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 | 2017-07-17 |
| Decision Date | 2018-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815614020828 | K172155 | 000 |
| 10815614020811 | K172155 | 000 |
| 30815614020808 | K172155 | 000 |