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FDA 510(k)

KALTOSTAT(TM) WOUND DRESSING

K-Number: K892364 · 1989-06-23

ApplicantCalgon Vestal Div.
Decision Date1989-06-23
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

KALTOSTAT(TM) WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Calgon Vestal Div.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K892364. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KALTOSTAT(TM) WOUND DRESSING?

KALTOSTAT(TM) WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Calgon Vestal Div.. The 510(k) number is K892364.

When did KALTOSTAT(TM) WOUND DRESSING receive FDA 510(k) clearance?

KALTOSTAT(TM) WOUND DRESSING received FDA 510(k) clearance on 1989-06-23, under 510(k) number K892364.

Who is the listed applicant for KALTOSTAT(TM) WOUND DRESSING?

The FDA 510(k) record lists Calgon Vestal Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KALTOSTAT(TM) WOUND DRESSING?

The FDA product code for KALTOSTAT(TM) WOUND DRESSING is FRO. This falls under the Anesthesiology category.

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Other records listing Calgon Vestal Div. 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.

K944494ALSA-KLENZK944033BILL EVANS-KLENZK942270SAF-GEL HYDRATING DERMAL WOUND DRESSINGK931477AMERSEK931342LPHK931816VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM

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Related Devices (Code: FRO)

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.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, 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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