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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Formulations, Balanced Salt Solutions
510(k) Number K870486
Device Name EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509
Applicant
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact DAVID BAGLEY
Correspondent
Sigma Chemical Co.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact DAVID BAGLEY
Regulation Number864.2875
Classification Product Code
KIP  
Date Received02/03/1987
Decision Date 03/30/1987
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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