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FDA 510(k)

DERATA MEDI-JECTOR IV

K-Number: K864561 · 1987-02-19

ApplicantDerata Corp.
Decision Date1987-02-19
Product CodeKZE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DERATA MEDI-JECTOR IV is the device name listed in this FDA 510(k) record. The listed applicant is Derata Corp.. It received FDA 510(k) clearance on 1987-02-19 under 510(k) number K864561. 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 DERATA MEDI-JECTOR IV?

DERATA MEDI-JECTOR IV is a medical device that received FDA 510(k) clearance on 1987-02-19. The listed applicant is Derata Corp.. The 510(k) number is K864561.

When did DERATA MEDI-JECTOR IV receive FDA 510(k) clearance?

DERATA MEDI-JECTOR IV received FDA 510(k) clearance on 1987-02-19, under 510(k) number K864561.

Who is the listed applicant for DERATA MEDI-JECTOR IV?

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

What is the FDA product code for DERATA MEDI-JECTOR IV?

The FDA product code for DERATA MEDI-JECTOR IV is KZE.

Related Clinical Trials

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Other records listing Derata Corp. 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.

K883847DERATA MEDI-JECTOR VK844244DERATA MEDI-JECTOR PROK844111DERATA MEDI-JECTOR IIIK834044MEDI-JECTOR IIK772129MEDI-JECTOR

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

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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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