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FDA 510(k)

TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE

K-Number: K080648 · 2008-05-07

ApplicantOre-Medix, LLC
Decision Date2008-05-07
Product CodeQSY
DecisionSubstantially Equivalent

Device Summary

TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE is the device name listed in this FDA 510(k) record. The listed applicant is Ore-Medix, LLC. It received FDA 510(k) clearance on 2008-05-07 under 510(k) number K080648. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE?

TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE is a medical device that received FDA 510(k) clearance on 2008-05-07. The listed applicant is Ore-Medix, LLC. The 510(k) number is K080648.

When did TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE receive FDA 510(k) clearance?

TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE received FDA 510(k) clearance on 2008-05-07, under 510(k) number K080648.

Who is the listed applicant for TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE?

The FDA 510(k) record lists Ore-Medix, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE?

The FDA product code for TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE is QSY.

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Related Devices (Code: QSY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.K251700Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm (FG100500); Ganymede 15cm x 15cm (FG100600); Ganymede 20cm x 30cm (FG100700); Ganymede 25cm x 25cm (FG100800); Ganymede 30cm x 30cm (FG100900); Ganymede 40cm x 40cm (FG100999); Ganymede 7.5cm x 120cm (FG100100); Ganymede-X 2cm diameter (FG100301); Ganymede-X 5cm x 5cm (FG100401); Ganymede-X 10cm x 10cm (FG100501); Ganymede-X 15cm x 15cm (FG100601); Ganymede-X 20cm x 30cm (FG100701); Ganymede-X 25cmSpeciality Fibres and Materials LimitedK250319MFUSE (MS001)Machina Medical, Inc.K253609TRAUMAGEL® 2.0 Hemostatic GelCresilon, Inc.K240713TRAUMAGEL®Cresilon, Inc.K240097Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)Ushare Medical, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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