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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name reagent, occult blood
510(k) Number K041297
Device Name POLYMEDCO OC LIGHT FOBT TEST
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 Number864.6550
Classification Product Code
KHE  
Date Received05/14/2004
Decision Date 08/12/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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