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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hexokinase, Glucose
510(k) Number K020852
Device Name POLY-CHEM GLUCOSE
Applicant
Polymedco, Inc.
510 Furnace Dock Rd.
Cortlandt Manor,  NY  10567
Applicant Contact HELEN LANDICHO
Correspondent
Polymedco, Inc.
5449 Reseach Dr.
Canton,  MI  48188
Correspondent Contact Cindy Williams
Regulation Number862.1345
Classification Product Code
CFR  
Date Received03/15/2002
Decision Date 07/03/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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