The following data is part of a premarket notification filed by Hemostasis, Llc with the FDA for Osteoseal Bone Hemostat.
| Device ID | K142348 |
| 510k Number | K142348 |
| Device Name: | OsteoSeal Bone Hemostat |
| Classification | Wax, Bone |
| Applicant | HEMOSTASIS, LLC 5000 TOWNSHIP PARKWAY St. Paul, MN 55110 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath HEMOSTASIS, LLC 5000 TOWNSHIP PARKWAY St. Paul, MN 55110 |
| Product Code | MTJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-22 |
| Decision Date | 2015-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858439001569 | K142348 | 000 |
| 00858439001545 | K142348 | 000 |
| 00858439001514 | K142348 | 000 |