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FDA 510(k)

PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM

K-Number: K110456 · 2011-03-02

ApplicantPharmajet, Inc.
Decision Date2011-03-02
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Pharmajet, Inc.. It received FDA 510(k) clearance on 2011-03-02 under 510(k) number K110456. The device is classified under product code KZE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM?

PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-03-02. The listed applicant is Pharmajet, Inc.. The 510(k) number is K110456.

When did PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM receive FDA 510(k) clearance?

PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM received FDA 510(k) clearance on 2011-03-02, under 510(k) number K110456.

Who is the listed applicant for PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM?

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

What is the FDA product code for PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM?

The FDA product code for PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEM is KZE.

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Other records listing Pharmajet, 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.

K111517PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATIK081532PHARMAJET NEEDLE-FREE INJECTION SYSTEM

Related Devices (Code: KZE)

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.

K121270BIOJECT NEEDLE-FREE INJECTION MANAGEMENT SYSTEMBioject Medical Technologies, Inc.K111517PHARMAJET STRATIS 0.5 ML NEEDLE-FREE INJECTION SYSTEM MODEL 501-01, STRATIS INJECTOR CATALOG 501-10, STRATIS RESET STATIPharmajet, Inc.K090959LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RAD'Antonio Consultants International, Inc. (Dci)K090003ZETAJETBioject, Inc.K081532PHARMAJET NEEDLE-FREE INJECTION SYSTEMPharmajet, Inc.K082138AIRGENT, MODEL AG7000010Perfaction, Inc.

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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