The following data is part of a premarket notification filed by Hemostasis, Llc with the FDA for Nexstat Plus And Nexfoam Plus Topical Hemostat Dressing.
Device ID | K122886 |
510k Number | K122886 |
Device Name: | NEXSTAT PLUS AND NEXFOAM PLUS TOPICAL HEMOSTAT DRESSING |
Classification | Dressing, Wound, Drug |
Applicant | HEMOSTASIS, LLC 4486 TIMBERLINE CT Vadnais Hts, MN 55127 |
Contact | Bernard Horwath |
Correspondent | Bernard Horwath HEMOSTASIS, LLC 4486 TIMBERLINE CT Vadnais Hts, MN 55127 |
Product Code | FRO |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-09-20 |
Decision Date | 2012-11-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00858439001408 | K122886 | 000 |
00858439001293 | K122886 | 000 |