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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Atomic Absorption Spectrophotometer, General Use
510(k) Number K875098
Device Name CIBA CORNING MODEL 644
Applicant
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Applicant Contact William J Pignato
Correspondent
Ciba Corning Diagnostics Corp.
333 Coney St.
East Walpole,  MA  02032
Correspondent Contact William J Pignato
Regulation Number862.2850
Classification Product Code
JXR  
Date Received12/10/1987
Decision Date 03/03/1988
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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