AIRMED SMOKE EVACUATION & FILTER

Volumetric/manometric, Carbon-dioxide

JAMES L. GERACI & ASSOCIATES, INC.

The following data is part of a premarket notification filed by James L. Geraci & Associates, Inc. with the FDA for Airmed Smoke Evacuation & Filter.

Pre-market Notification Details

Device IDK820091
510k NumberK820091
Device Name:AIRMED SMOKE EVACUATION & FILTER
ClassificationVolumetric/manometric, Carbon-dioxide
Applicant JAMES L. GERACI & ASSOCIATES, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeCIE  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-01-13
Decision Date1982-02-24

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