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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Clearing
510(k) Number K874461
Device Name HEMO-SOL
Applicant
Chem Pharm, Inc.
P.O. Box 20717
Dallas,  TX  75220
Applicant Contact ALEX TARSI
Correspondent
Chem Pharm, Inc.
P.O. Box 20717
Dallas,  TX  75220
Correspondent Contact ALEX TARSI
Regulation Number864.4010
Classification Product Code
KEM  
Date Received10/29/1987
Decision Date 12/04/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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