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FDA 510(k)

MEDAJET XL - JET INJECTOR

K-Number: K850754 · 1985-12-10

ApplicantMada Medical Products, Inc.
Decision Date1985-12-10
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDAJET XL - JET INJECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Mada Medical Products, Inc.. It received FDA 510(k) clearance on 1985-12-10 under 510(k) number K850754. 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 MEDAJET XL - JET INJECTOR?

MEDAJET XL - JET INJECTOR is a medical device that received FDA 510(k) clearance on 1985-12-10. The listed applicant is Mada Medical Products, Inc.. The 510(k) number is K850754.

When did MEDAJET XL - JET INJECTOR receive FDA 510(k) clearance?

MEDAJET XL - JET INJECTOR received FDA 510(k) clearance on 1985-12-10, under 510(k) number K850754.

Who is the listed applicant for MEDAJET XL - JET INJECTOR?

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

What is the FDA product code for MEDAJET XL - JET INJECTOR?

The FDA product code for MEDAJET XL - JET INJECTOR is KZE.

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Other records listing Mada Medical Products, 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.

K003862MADA WHEELCHAIRSK002943WHEELCHAIR, MECHANICAL SERIES MODEL 3100K950777OXYGEN REGULATORK930947PROMENADEK930949VOYAGEK921611MADAVAC 190

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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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