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FDA 510(k)

DERMASAFE(TH) HYPOALLERGENIC

K-Number: K914094 · 1991-10-28

ApplicantMulti-Com Sdn Bhd
Decision Date1991-10-28
Product CodeLYY
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERMASAFE(TH) HYPOALLERGENIC is the device name listed in this FDA 510(k) record. The listed applicant is Multi-Com Sdn Bhd. It received FDA 510(k) clearance on 1991-10-28 under 510(k) number K914094. The device is classified under product code LYY. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DERMASAFE(TH) HYPOALLERGENIC?

DERMASAFE(TH) HYPOALLERGENIC is a medical device that received FDA 510(k) clearance on 1991-10-28. The listed applicant is Multi-Com Sdn Bhd. The 510(k) number is K914094.

When did DERMASAFE(TH) HYPOALLERGENIC receive FDA 510(k) clearance?

DERMASAFE(TH) HYPOALLERGENIC received FDA 510(k) clearance on 1991-10-28, under 510(k) number K914094.

Who is the listed applicant for DERMASAFE(TH) HYPOALLERGENIC?

The FDA 510(k) record lists Multi-Com Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DERMASAFE(TH) HYPOALLERGENIC?

The FDA product code for DERMASAFE(TH) HYPOALLERGENIC is LYY.

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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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