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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Gas Generating
510(k) Number K820010
Device Name GAS GENERATING KIT, CO2
Applicant
Oxoid U.S.A., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Oxoid U.S.A., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.2580
Classification Product Code
KZJ  
Date Received01/05/1982
Decision Date 01/28/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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