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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Automated Platelet Counting
510(k) Number K840948
Device Name CLEAR POROUS PLASTIC-HYPOALLERGENIC
Applicant
GAINOR MEDICAL
MD 
Correspondent
GAINOR MEDICAL
MD 
Regulation Number864.5200
Classification Product Code
GKX  
Date Received07/06/1984
Decision Date 08/14/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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