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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, Potassium
510(k) Number K112408
Device Name POLY-CHEM 90 ISE MODULE
Applicant
Polymedco, Inc.
510 Furnace Dock Rd.
Cortlandt Manor,  NY  10567
Applicant Contact HELEN LANDICHO
Correspondent
Polymedco, Inc.
510 Furnace Dock Rd.
Cortlandt Manor,  NY  10567
Correspondent Contact HELEN LANDICHO
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   JGS  
Date Received08/22/2011
Decision Date 11/04/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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