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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, Chloride
510(k) Number K863395
Device Name WESCOR SWEAT.CHEK SWEAT CONDUCTIVITY ANALYZER
Applicant
Wescor, Inc.
459 S. Main
Logan,  UT  84321
Applicant Contact WAYNE K BARLOW
Correspondent
Wescor, Inc.
459 S. Main
Logan,  UT  84321
Correspondent Contact WAYNE K BARLOW
Regulation Number862.1170
Classification Product Code
CGZ  
Date Received09/03/1986
Decision Date 05/24/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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