INTRAJECT— 510(k) K802332

Substantially Equivalent

General Medical Engineering Corp.

FDA 510(k) clearance K802332 for INTRAJECT, Substantially Equivalent on 1980-12-22. Applicant: General Medical Engineering Corp.. Device class: 1.

Clearance details

Applicant: General Medical Engineering Corp.
Product code: Code KYG
Device class: Class 1
Regulation: 21 CFR 886.4360
Advisory panel: Ophthalmic
Date received: 1980-09-23
Decision date: 1980-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KYG

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K993591 — BLADEWORKS DISPOSABLE ALK TUBING1999-12-28
K981116 — SOVEREIGN CATARACT EXTRACTION SYSTEM1998-05-19
K980647 — EYE IRRIGATOR MODEL #20201998-05-15

Data sourced from openFDA. This site is unofficial and independent of the FDA.