FDA 510(k)

QUALTEX NEEDLE COUNTERS

K-Number: K903947 · 1990-10-30

Decision Date1990-10-30

Product CodeMMK

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

QUALTEX NEEDLE COUNTERS is the device name listed in this FDA 510(k) record. The listed applicant is Deroyal Industries, Inc.. It received FDA 510(k) clearance on 1990-10-30 under 510(k) number K903947. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUALTEX NEEDLE COUNTERS?

QUALTEX NEEDLE COUNTERS is a medical device that received FDA 510(k) clearance on 1990-10-30. The listed applicant is Deroyal Industries, Inc.. The 510(k) number is K903947.

When did QUALTEX NEEDLE COUNTERS receive FDA 510(k) clearance?

QUALTEX NEEDLE COUNTERS received FDA 510(k) clearance on 1990-10-30, under 510(k) number K903947.

Who is the listed applicant for QUALTEX NEEDLE COUNTERS?

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

What is the FDA product code for QUALTEX NEEDLE COUNTERS?

The FDA product code for QUALTEX NEEDLE COUNTERS is MMK.

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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.