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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K790336
Device Name UNION CARBIDE CORP. COMPUTER INTERFACE
Applicant
Union Carbide Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Union Carbide Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2100
Classification Product Code
JQP  
Date Received02/21/1979
Decision Date 04/04/1979
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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