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FDA 510(k)

MANAN VS ACCESS NEEDLE/SET

K-Number: K980372 · 1998-04-27

Decision Date1998-04-27
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MANAN VS ACCESS NEEDLE/SET 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 1998-04-27 under 510(k) number K980372. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MANAN VS ACCESS NEEDLE/SET?

MANAN VS ACCESS NEEDLE/SET is a medical device that received FDA 510(k) clearance on 1998-04-27. The listed applicant is Medical Device Technologies, Inc.. The 510(k) number is K980372.

When did MANAN VS ACCESS NEEDLE/SET receive FDA 510(k) clearance?

MANAN VS ACCESS NEEDLE/SET received FDA 510(k) clearance on 1998-04-27, under 510(k) number K980372.

Who is the listed applicant for MANAN VS ACCESS NEEDLE/SET?

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 VS ACCESS NEEDLE/SET?

The FDA product code for MANAN VS ACCESS NEEDLE/SET is FGE.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Medical Device Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 46 devices →

Related Devices (Code: FGE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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