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FDA 510(k)

ULCUFLEX HYDROCOLLOID PASTE

K-Number: K920368 · 1992-03-26

ApplicantIndustrias Palex C/O Dma Med-Chem Corp.
Decision Date1992-03-26
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ULCUFLEX HYDROCOLLOID PASTE is the device name listed in this FDA 510(k) record. The listed applicant is Industrias Palex C/O Dma Med-Chem Corp.. It received FDA 510(k) clearance on 1992-03-26 under 510(k) number K920368. The device is classified under product code KMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULCUFLEX HYDROCOLLOID PASTE?

ULCUFLEX HYDROCOLLOID PASTE is a medical device that received FDA 510(k) clearance on 1992-03-26. The listed applicant is Industrias Palex C/O Dma Med-Chem Corp.. The 510(k) number is K920368.

When did ULCUFLEX HYDROCOLLOID PASTE receive FDA 510(k) clearance?

ULCUFLEX HYDROCOLLOID PASTE received FDA 510(k) clearance on 1992-03-26, under 510(k) number K920368.

Who is the listed applicant for ULCUFLEX HYDROCOLLOID PASTE?

The FDA 510(k) record lists Industrias Palex C/O Dma Med-Chem Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULCUFLEX HYDROCOLLOID PASTE?

The FDA product code for ULCUFLEX HYDROCOLLOID PASTE is KMF.

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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 Industrias Palex C/O Dma Med-Chem 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.

K920740EPISENSOR PLUSK920367ULCUFLEX HYDROCULLOID DRESSINGK920366ULCUFLEX HYDROCOLOID POWDERK871628PALEX (R) OSTOMY

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

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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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