FDA 510(k)

MANAN LIVER BIOPSY KIT

K-Number: K980452 · 1998-02-18

ApplicantMedical Device Technologies, Inc.

Decision Date1998-02-18

Product CodeKNW

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

MANAN LIVER BIOPSY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Device Technologies, Inc.. It received FDA 510(k) clearance on 1998-02-18 under 510(k) number K980452. The device is classified under product code KNW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANAN LIVER BIOPSY KIT?

MANAN LIVER BIOPSY KIT is a medical device that received FDA 510(k) clearance on 1998-02-18. The listed applicant is Medical Device Technologies, Inc.. The 510(k) number is K980452.

When did MANAN LIVER BIOPSY KIT receive FDA 510(k) clearance?

MANAN LIVER BIOPSY KIT received FDA 510(k) clearance on 1998-02-18, under 510(k) number K980452.

Who is the listed applicant for MANAN LIVER BIOPSY KIT?

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

What is the FDA product code for MANAN LIVER BIOPSY KIT?

The FDA product code for MANAN LIVER BIOPSY KIT is KNW.

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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.