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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 K863617
Device Name ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)
Applicant
Hi Chem, Inc.
231 N. Puente St.
P.O. Box 1599
Brea,  CA  92621
Applicant Contact WYNN STOCKING
Correspondent
Hi Chem, Inc.
231 N. Puente St.
P.O. Box 1599
Brea,  CA  92621
Correspondent Contact WYNN STOCKING
Regulation Number862.1665
Classification Product Code
JGS  
Date Received09/16/1986
Decision Date 10/24/1986
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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