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FDA 510(k)

HYCURE ORAL / HYCURE ORAL SMART GEL

K-Number: K994339 · 2000-03-22

ApplicantThe Hymed Group Corp.
Decision Date2000-03-22
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

HYCURE ORAL / HYCURE ORAL SMART GEL is the device name listed in this FDA 510(k) record. The listed applicant is The Hymed Group Corp.. It received FDA 510(k) clearance on 2000-03-22 under 510(k) number K994339. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYCURE ORAL / HYCURE ORAL SMART GEL?

HYCURE ORAL / HYCURE ORAL SMART GEL is a medical device that received FDA 510(k) clearance on 2000-03-22. The listed applicant is The Hymed Group Corp.. The 510(k) number is K994339.

When did HYCURE ORAL / HYCURE ORAL SMART GEL receive FDA 510(k) clearance?

HYCURE ORAL / HYCURE ORAL SMART GEL received FDA 510(k) clearance on 2000-03-22, under 510(k) number K994339.

Who is the listed applicant for HYCURE ORAL / HYCURE ORAL SMART GEL?

The FDA 510(k) record lists The Hymed Group Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYCURE ORAL / HYCURE ORAL SMART GEL?

The FDA product code for HYCURE ORAL / HYCURE ORAL SMART GEL is KGN.

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Other records listing The Hymed Group Corp. as applicant

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.

K061227HYDROLYZED COLLAGEN/AG WOUND GEL WITH SILVERK961930CHONDROPROTECK960686HYCOATK955506HYCURE

Related Devices (Code: KGN)

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.

K260652ColActive PlusCovalon Technologies, Ltd.K260711Accelagen Plus Surgical Matrix, 1cc (CG-01AP);Accelagen Plus Surgical Matrix, 3cc (CG-03AP);Accelagen Plus Surgical Matrix, 5cc (CG-05AP);Accelagen Plus Surgical Strip, 125x25x2mm (CG-125X25AP);Accelagen Plus Surgical Strip, 250x25x2mm (CG-250X25AP)Berkeley Advanced BiomaterialsK260596Collagen Wound PowderVentris MedicalK260669Endoform Dermal TemplateAroa Biosurgery , Ltd.K253521ECMT-100 WMDEcm Therapeutics, Inc.K253204CatalyzeBioTissue Holdings, 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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