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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resins, Ion-Exchange
510(k) Number K831027
Device Name EXTRELUT QE EXTRACTION COLUMNS
Applicant
Emd Chemicals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Emd Chemicals, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2230
Classification Product Code
KEA  
Date Received03/30/1983
Decision Date 05/16/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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