DISPOSABLE MICRO-INFUSION SYSTEM

Syringe, Piston

ORANGE MEDICAL INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Orange Medical Instruments, Inc. with the FDA for Disposable Micro-infusion System.

Pre-market Notification Details

Device IDK822928
510k NumberK822928
Device Name:DISPOSABLE MICRO-INFUSION SYSTEM
ClassificationSyringe, Piston
Applicant ORANGE MEDICAL INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-10-04
Decision Date1982-10-26

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