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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Sodium
510(k) Number K895936
Device Name EASYLYTE SODIUM/POTASSIUM/CHLORIDE ANALYZER
Applicant
Medica Corp.
14 Deangelo Dr.
Bedford,  MA  01730
Applicant Contact HOWARD GUTHERMANN
Correspondent
Medica Corp.
14 Deangelo Dr.
Bedford,  MA  01730
Correspondent Contact HOWARD GUTHERMANN
Regulation Number862.1665
Classification Product Code
JGS  
Subsequent Product Codes
CEM   CGZ  
Date Received10/11/1989
Decision Date 12/12/1989
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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