OMED SILICONE INSTRUMENT COVERS

Instrument, Surgical, Disposable

OMEGA-MED INTL., INC.

The following data is part of a premarket notification filed by Omega-med Intl., Inc. with the FDA for Omed Silicone Instrument Covers.

Pre-market Notification Details

Device IDK810883
510k NumberK810883
Device Name:OMED SILICONE INSTRUMENT COVERS
ClassificationInstrument, Surgical, Disposable
Applicant OMEGA-MED INTL., INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeKDC  
CFR Regulation Number878.4800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-04-01
Decision Date1981-04-23

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