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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Potentiating For In Vitro Diagnostic Use
510(k) Number K791113
Device Name LOW IONIC STRENGTH SOLUTION (LISS)
Applicant
Hyland Therapeutic Div., Travenol Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hyland Therapeutic Div., Travenol Laboratories
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.9600
Classification Product Code
KSG  
Date Received06/15/1979
Decision Date 06/28/1979
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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