NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE

Dressing, Wound, Drug

HEMOSTASIS, LLC

The following data is part of a premarket notification filed by Hemostasis, Llc with the FDA for Nexstat (tm) Topical Hemostat Powder; Nexfoam (r) Topical Sponge.

Pre-market Notification Details

• Device ID: K102459
• 510k Number: K102459
• Device Name: NEXSTAT (TM) TOPICAL HEMOSTAT POWDER; NEXFOAM (R) TOPICAL SPONGE
• Classification: Dressing, Wound, Drug
• 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: FRO
• CFR Regulation Number: 510(k) Premarket Notification [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-27
• Decision Date: 2010-12-03
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00858439001477	K102459	000
00858439001606	K102459	000
00858439001439	K102459	000
00858439001989	K102459	000