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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toluidine Blue
510(k) Number K844640
Device Name POLYSTAT, BIOLOGICAL STAIN
Applicant
Surgipath Medical Industries, Inc.
P.O. Box 769
Grayslake,  IL  60030
Applicant Contact KEN URBAN
Correspondent
Surgipath Medical Industries, Inc.
P.O. Box 769
Grayslake,  IL  60030
Correspondent Contact KEN URBAN
Regulation Number864.1850
Classification Product Code
IAB  
Date Received11/28/1984
Decision Date 01/30/1985
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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