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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Vanilmandelic, Diazo, P-Nitroaniline/Vanillin
510(k) Number K934977
Device Name MODEL 5500 CEAS
Applicant
Esa, Inc.
45 Wiggins Ave.
Bedford,  MA  01730
Applicant Contact JAMES MAYOL
Correspondent
Esa, Inc.
45 Wiggins Ave.
Bedford,  MA  01730
Correspondent Contact JAMES MAYOL
Regulation Number862.1795
Classification Product Code
CDF  
Date Received10/19/1993
Decision Date 01/11/1994
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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