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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name High Pressure Liquid Chromatography, Codeine
510(k) Number K832590
Device Name MOUTH-TO-MOUTH SHIELD APPLICATOR
Applicant
Mem, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Mem, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3270
Classification Product Code
LAE  
Date Received08/02/1983
Decision Date 10/14/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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