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FDA 510(k)

JET SYRINGE MODEL-100500

K-Number: K003741 · 2001-06-01

ApplicantEquidyne Systems, Inc.
Decision Date2001-06-01
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

JET SYRINGE MODEL-100500 is the device name listed in this FDA 510(k) record. The listed applicant is Equidyne Systems, Inc.. It received FDA 510(k) clearance on 2001-06-01 under 510(k) number K003741. 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 JET SYRINGE MODEL-100500?

JET SYRINGE MODEL-100500 is a medical device that received FDA 510(k) clearance on 2001-06-01. The listed applicant is Equidyne Systems, Inc.. The 510(k) number is K003741.

When did JET SYRINGE MODEL-100500 receive FDA 510(k) clearance?

JET SYRINGE MODEL-100500 received FDA 510(k) clearance on 2001-06-01, under 510(k) number K003741.

Who is the listed applicant for JET SYRINGE MODEL-100500?

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

What is the FDA product code for JET SYRINGE MODEL-100500?

The FDA product code for JET SYRINGE MODEL-100500 is KZE.

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Other records listing Equidyne Systems, 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.

K022502INJEX 30 NEEDLE FREE INJECTION SYSTEM, MODEL 100000K022148INJEX 30 NEEDLE FREE INJECTION SYSTEMK003864INJEX 50 SYSTEMK945873HYPEX(TM) JET INJECTOR

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.K110456PHARMAJET 0.1 ML INTRADERMAL NEEDLE-FREE INJECTION SYSTEMPharmajet, Inc.K090959LECTRAJET NEEDLE-FREE INJECTION SYSTEM, MODEL: M3 RAD'Antonio Consultants International, Inc. (Dci)K090003ZETAJETBioject, Inc.K081532PHARMAJET NEEDLE-FREE INJECTION SYSTEMPharmajet, Inc.

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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