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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hematoxylin
510(k) Number K821533
Device Name HEMATOXYLIN I
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 Number864.1850
Classification Product Code
HYJ  
Date Received05/21/1982
Decision Date 06/10/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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