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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media And Components, Synthetic Cell And Tissue Culture
510(k) Number K883139
Device Name MEDIUM 199 EBSS/NUTRIENT MIXTURE F-10 #200-2110
Applicant
J R SCIENTIFIC
ONE HARTER AVE., SUITE B
P.O. BOX 1937
WOODLAND,  CA  95695
Applicant Contact MARILYN G KONISH
Correspondent
J R SCIENTIFIC
ONE HARTER AVE., SUITE B
P.O. BOX 1937
WOODLAND,  CA  95695
Correspondent Contact MARILYN G KONISH
Regulation Number864.2220
Classification Product Code
KIT  
Date Received07/26/1988
Decision Date 08/15/1988
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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