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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrators, Ethyl Alcohol
510(k) Number K973054
Device Name ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS
Applicant
Emd Chemicals, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact ANNA G BENTLEY
Correspondent
Emd Chemicals, Inc.
480 Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact ANNA G BENTLEY
Regulation Number862.3200
Classification Product Code
DNN  
Date Received08/15/1997
Decision Date 10/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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