FDA 510(k)

ULTIMAX (GREEN POWDER FREE EXAMINATION)

K-Number: K943869 · 1995-02-21

ApplicantWembley Rubber Products (M) Sdn Bhd

Decision Date1995-02-21

Product CodeLYY

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ULTIMAX (GREEN POWDER FREE EXAMINATION) is the device name listed in this FDA 510(k) record. The listed applicant is Wembley Rubber Products (M) Sdn Bhd. It received FDA 510(k) clearance on 1995-02-21 under 510(k) number K943869. 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 ULTIMAX (GREEN POWDER FREE EXAMINATION)?

ULTIMAX (GREEN POWDER FREE EXAMINATION) is a medical device that received FDA 510(k) clearance on 1995-02-21. The listed applicant is Wembley Rubber Products (M) Sdn Bhd. The 510(k) number is K943869.

When did ULTIMAX (GREEN POWDER FREE EXAMINATION) receive FDA 510(k) clearance?

ULTIMAX (GREEN POWDER FREE EXAMINATION) received FDA 510(k) clearance on 1995-02-21, under 510(k) number K943869.

Who is the listed applicant for ULTIMAX (GREEN POWDER FREE EXAMINATION)?

The FDA 510(k) record lists Wembley Rubber Products (M) Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTIMAX (GREEN POWDER FREE EXAMINATION)?

The FDA product code for ULTIMAX (GREEN POWDER FREE EXAMINATION) is LYY.

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Other records listing Wembley Rubber Products (M) Sdn Bhd as applicant

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Related Devices (Code: 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.