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 |