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FDA 510(k)

HYDROSKIN WOUND DRESSING

K-Number: K942815 · 1994-07-11

ApplicantHymedix Intl., Inc.
Decision Date1994-07-11
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent for Some Indications

Device Summary

HYDROSKIN WOUND DRESSING is the device name listed in this FDA 510(k) record. The listed applicant is Hymedix Intl., Inc.. It received FDA 510(k) clearance on 1994-07-11 under 510(k) number K942815. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the HYDROSKIN WOUND DRESSING?

HYDROSKIN WOUND DRESSING is a medical device that received FDA 510(k) clearance on 1994-07-11. The listed applicant is Hymedix Intl., Inc.. The 510(k) number is K942815.

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

HYDROSKIN WOUND DRESSING received FDA 510(k) clearance on 1994-07-11, under 510(k) number K942815.

Who is the listed applicant for HYDROSKIN WOUND DRESSING?

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

What is the FDA product code for HYDROSKIN WOUND DRESSING?

The FDA product code for HYDROSKIN WOUND DRESSING is KMF.

Related Clinical Trials

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.

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Other records listing Hymedix Intl., 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.

K942419HYDRO-S WOUND GEL

Related Devices (Code: KMF)

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.

K241916TearRepair Liquid Skin ProtectantOptmed, Inc.K182733Rochal Bioshield Silicone FilmRochal Industries, LLCK171148Aleo BME Liquid BandageAleo Bme, Inc.K153571Cavilon Advanced High Endurance Skin Protectant3M HealthcareK160684Atteris No-Sting Skin ProtectantRochal Industries, LLCK120059LIQUID BANDAGEChesson Laboratory Associates, 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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