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FDA 510(k)

GERTIE MARX NEEDLE

K-Number: K931644 · 1993-09-22

ApplicantIntl. Medical-Dental Products USA, Inc.
Decision Date1993-09-22
Product CodeBSP
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

GERTIE MARX NEEDLE is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Medical-Dental Products USA, Inc.. It received FDA 510(k) clearance on 1993-09-22 under 510(k) number K931644. The device is classified under product code BSP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GERTIE MARX NEEDLE?

GERTIE MARX NEEDLE is a medical device that received FDA 510(k) clearance on 1993-09-22. The listed applicant is Intl. Medical-Dental Products USA, Inc.. The 510(k) number is K931644.

When did GERTIE MARX NEEDLE receive FDA 510(k) clearance?

GERTIE MARX NEEDLE received FDA 510(k) clearance on 1993-09-22, under 510(k) number K931644.

Who is the listed applicant for GERTIE MARX NEEDLE?

The FDA 510(k) record lists Intl. Medical-Dental Products USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GERTIE MARX NEEDLE?

The FDA product code for GERTIE MARX NEEDLE is BSP.

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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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