FDA 510(k)

MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC

K-Number: K072486 · 2008-08-06

ApplicantHem Con Medical Technologies, Inc.

Decision Date2008-08-06

Product CodeQSY

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC is the device name listed in this FDA 510(k) record. The listed applicant is Hem Con Medical Technologies, Inc.. It received FDA 510(k) clearance on 2008-08-06 under 510(k) number K072486. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC?

MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC is a medical device that received FDA 510(k) clearance on 2008-08-06. The listed applicant is Hem Con Medical Technologies, Inc.. The 510(k) number is K072486.

When did MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC receive FDA 510(k) clearance?

MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC received FDA 510(k) clearance on 2008-08-06, under 510(k) number K072486.

Who is the listed applicant for MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC?

The FDA 510(k) record lists Hem Con Medical Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC?

The FDA product code for MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC is QSY.

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Other records listing Hem Con Medical Technologies, Inc. as applicant

K153582Prometheus ChitoGauze XR PRO K103641GUARDACARE K111163CHITOGAUZE FUSION K102546CHITOGAUZE K092357CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2 K090026CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266

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Related Devices (Code: QSY)

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 Limited K250319MFUSE (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.