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FDA 510(k)

CUTICOVER SKIN BARRIER DEVICE

K-Number: K042955 · 2006-06-19

ApplicantD & D Holdings, LLC
Decision Date2006-06-19
Product CodeKMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CUTICOVER SKIN BARRIER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is D & D Holdings, LLC. It received FDA 510(k) clearance on 2006-06-19 under 510(k) number K042955. 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 CUTICOVER SKIN BARRIER DEVICE?

CUTICOVER SKIN BARRIER DEVICE is a medical device that received FDA 510(k) clearance on 2006-06-19. The listed applicant is D & D Holdings, LLC. The 510(k) number is K042955.

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

CUTICOVER SKIN BARRIER DEVICE received FDA 510(k) clearance on 2006-06-19, under 510(k) number K042955.

Who is the listed applicant for CUTICOVER SKIN BARRIER DEVICE?

The FDA 510(k) record lists D & D Holdings, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CUTICOVER SKIN BARRIER DEVICE?

The FDA product code for CUTICOVER SKIN BARRIER DEVICE 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

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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