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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Coagulation
510(k) Number K812906
Device Name ELVI BICLOT 816
Applicant
VOLU SOL MEDICAL INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
VOLU SOL MEDICAL INDUSTRIES
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.5400
Classification Product Code
KQG  
Date Received10/19/1981
Decision Date 07/22/1982
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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