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FDA 510(k)

BIOJECT JET INJECTION SYSTEM

K-Number: K920631 · 1994-06-28

ApplicantBioject, Inc.
Decision Date1994-06-28
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOJECT JET INJECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Bioject, Inc.. It received FDA 510(k) clearance on 1994-06-28 under 510(k) number K920631. 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 BIOJECT JET INJECTION SYSTEM?

BIOJECT JET INJECTION SYSTEM is a medical device that received FDA 510(k) clearance on 1994-06-28. The listed applicant is Bioject, Inc.. The 510(k) number is K920631.

When did BIOJECT JET INJECTION SYSTEM receive FDA 510(k) clearance?

BIOJECT JET INJECTION SYSTEM received FDA 510(k) clearance on 1994-06-28, under 510(k) number K920631.

Who is the listed applicant for BIOJECT JET INJECTION SYSTEM?

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

What is the FDA product code for BIOJECT JET INJECTION SYSTEM?

The FDA product code for BIOJECT JET INJECTION SYSTEM is KZE.

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Other records listing Bioject, 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.

K090003ZETAJETK050734COOL.CLICKK010623RECONSTITUTION KIT & VIAL CONNECTORK003908SEROJETK994384CLICKERK960373BIOJECTOR 2000 MODEL 1B02000

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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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