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FDA 510(k)

CUSTOM BURN DRESSING KIT

K-Number: K843788 · 1984-11-07

ApplicantHermitage Hospital Products, Inc.
Decision Date1984-11-07
Product CodeKGN
DecisionSubstantially Equivalent

Device Summary

CUSTOM BURN DRESSING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hermitage Hospital Products, Inc.. It received FDA 510(k) clearance on 1984-11-07 under 510(k) number K843788. The device is classified under product code KGN. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTOM BURN DRESSING KIT?

CUSTOM BURN DRESSING KIT is a medical device that received FDA 510(k) clearance on 1984-11-07. The listed applicant is Hermitage Hospital Products, Inc.. The 510(k) number is K843788.

When did CUSTOM BURN DRESSING KIT receive FDA 510(k) clearance?

CUSTOM BURN DRESSING KIT received FDA 510(k) clearance on 1984-11-07, under 510(k) number K843788.

Who is the listed applicant for CUSTOM BURN DRESSING KIT?

The FDA 510(k) record lists Hermitage Hospital Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUSTOM BURN DRESSING KIT?

The FDA product code for CUSTOM BURN DRESSING KIT is KGN.

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Other records listing Hermitage Hospital Products, Inc. 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.

K941802OR TOWELK923115CLINISORBK923116COMBINE II WETPROOF PADK891324HERMITEX SPONGEK863737SPONGES STERILE TWIN PAKT AND SINGLESK822987DRESSING SPONGE

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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

View on FDA Database →

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

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