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FDA 510(k)

IT HYDROCOLLOID WITH ZINC

K-Number: K973855 · 1997-12-01

ApplicantInnovative Technologies , Ltd.
Decision Date1997-12-01
Product CodeFRO
DecisionSubstantially Equivalent for Some Indications

Device Summary

IT HYDROCOLLOID WITH ZINC is the device name listed in this FDA 510(k) record. The listed applicant is Innovative Technologies , Ltd.. It received FDA 510(k) clearance on 1997-12-01 under 510(k) number K973855. 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 for Some Indications.

Frequently Asked Questions

What is the IT HYDROCOLLOID WITH ZINC?

IT HYDROCOLLOID WITH ZINC is a medical device that received FDA 510(k) clearance on 1997-12-01. The listed applicant is Innovative Technologies , Ltd.. The 510(k) number is K973855.

When did IT HYDROCOLLOID WITH ZINC receive FDA 510(k) clearance?

IT HYDROCOLLOID WITH ZINC received FDA 510(k) clearance on 1997-12-01, under 510(k) number K973855.

Who is the listed applicant for IT HYDROCOLLOID WITH ZINC?

The FDA 510(k) record lists Innovative Technologies , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IT HYDROCOLLOID WITH ZINC?

The FDA product code for IT HYDROCOLLOID WITH ZINC is FRO. This falls under the Anesthesiology category.

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Other records listing Innovative Technologies , Ltd. 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.

K983303INNOVATIVE TECHNOLOGIES HYDROCOLLOID AND INTELLIGENT HYDROCOLLOID WOUND DRESSINGSK982234AL-GEN CALCIUM ALGINATE DRESSINGK9826383M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214K981753INNOVATIVE TECHNOLOGIES TRANSPARENT FILM AND INTELLIGENT FILM WOUND DRESSINGK9809893M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSINGK980097FLEXIGEL-G HYDROGEL WOUND DRESSING

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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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