FDA 510(k)

MONOJECT MENGHINI SOFT TISSUE BIOPSY

K-Number: K843264 · 1984-12-17

Decision Date1984-12-17

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MONOJECT MENGHINI SOFT TISSUE BIOPSY is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1984-12-17 under 510(k) number K843264. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONOJECT MENGHINI SOFT TISSUE BIOPSY?

MONOJECT MENGHINI SOFT TISSUE BIOPSY is a medical device that received FDA 510(k) clearance on 1984-12-17. The listed applicant is Sherwood Medical Co.. The 510(k) number is K843264.

When did MONOJECT MENGHINI SOFT TISSUE BIOPSY receive FDA 510(k) clearance?

MONOJECT MENGHINI SOFT TISSUE BIOPSY received FDA 510(k) clearance on 1984-12-17, under 510(k) number K843264.

Who is the listed applicant for MONOJECT MENGHINI SOFT TISSUE BIOPSY?

The FDA 510(k) record lists Sherwood Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MONOJECT MENGHINI SOFT TISSUE BIOPSY?

The FDA product code for MONOJECT MENGHINI SOFT TISSUE BIOPSY is FMI.

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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.