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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Volumetric/Manometric, Carbon-Dioxide
510(k) Number K820091
Device Name AIRMED SMOKE EVACUATION & FILTER
Applicant
James L. Geraci & Associates, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
James L. Geraci & Associates, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1160
Classification Product Code
CIE  
Date Received01/13/1982
Decision Date 02/24/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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