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FDA 510(k)

SKIN BARRIER FILM

K-Number: K092712 · 2010-02-23

ApplicantLodestar Products, Inc.
Decision Date2010-02-23
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SKIN BARRIER FILM is the device name listed in this FDA 510(k) record. The listed applicant is Lodestar Products, Inc.. It received FDA 510(k) clearance on 2010-02-23 under 510(k) number K092712. 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 SKIN BARRIER FILM?

SKIN BARRIER FILM is a medical device that received FDA 510(k) clearance on 2010-02-23. The listed applicant is Lodestar Products, Inc.. The 510(k) number is K092712.

When did SKIN BARRIER FILM receive FDA 510(k) clearance?

SKIN BARRIER FILM received FDA 510(k) clearance on 2010-02-23, under 510(k) number K092712.

Who is the listed applicant for SKIN BARRIER FILM?

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

What is the FDA product code for SKIN BARRIER FILM?

The FDA product code for SKIN BARRIER FILM is KMF.

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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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