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FDA 510(k)

CONFIDOSE IM AUTO-INJECTOR

K-Number: K060389 · 2006-06-06

ApplicantPharma-Pen, Inc.
Decision Date2006-06-06
Product CodeKZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CONFIDOSE IM AUTO-INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Pharma-Pen, Inc.. It received FDA 510(k) clearance on 2006-06-06 under 510(k) number K060389. The device is classified under product code KZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CONFIDOSE IM AUTO-INJECTOR?

CONFIDOSE IM AUTO-INJECTOR is a medical device that received FDA 510(k) clearance on 2006-06-06. The listed applicant is Pharma-Pen, Inc.. The 510(k) number is K060389.

When did CONFIDOSE IM AUTO-INJECTOR receive FDA 510(k) clearance?

CONFIDOSE IM AUTO-INJECTOR received FDA 510(k) clearance on 2006-06-06, under 510(k) number K060389.

Who is the listed applicant for CONFIDOSE IM AUTO-INJECTOR?

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

What is the FDA product code for CONFIDOSE IM AUTO-INJECTOR?

The FDA product code for CONFIDOSE IM AUTO-INJECTOR is KZH.

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Related Devices (Code: KZH)

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.

K243232GripMateSynthon Hispania S.L.K213429AccuSert Needle InserterEmed Technologies CorporationK163400Orbit InserterYpsomed AGK160860MiniMed Quick-serterMedtronic MinimedK124026LOBSTER AUTO-INJECTORScandinavian Health LimitedK122837AUTOJECT 2 FOR GLASSY SYRINGEOwen Mumford, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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