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FDA 510(k)

INTRAJECT

K-Number: K802332 · 1980-12-22

ApplicantGeneral Medical Engineering Corp.
Decision Date1980-12-22
Product CodeKYG
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

INTRAJECT is the device name listed in this FDA 510(k) record. The listed applicant is General Medical Engineering Corp.. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K802332. The device is classified under product code KYG. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAJECT?

INTRAJECT is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is General Medical Engineering Corp.. The 510(k) number is K802332.

When did INTRAJECT receive FDA 510(k) clearance?

INTRAJECT received FDA 510(k) clearance on 1980-12-22, under 510(k) number K802332.

Who is the listed applicant for INTRAJECT?

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

What is the FDA product code for INTRAJECT?

The FDA product code for INTRAJECT is KYG.

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Related Devices (Code: KYG)

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.

K010353MED-LOGICS DISPOSABLE ALK TUBINGMed-Logics, Inc.K003036TURBO-FLOW INFUSION CANNULA 19 GAGE,20 GAGE,23 GAGE, 25 GAGE, MODEL 101019,101020,101023,101025Retinalabs.ComK993591BLADEWORKS DISPOSABLE ALK TUBINGBlade Works, Inc.K981116SOVEREIGN CATARACT EXTRACTION SYSTEMAllergan, Inc.K980647EYE IRRIGATOR MODEL #2020Eye-Deal Ocular Safety Products, Inc.K974561MOISTAIR FLUID AIR TUBING SETAmerican Medical Devices, 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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