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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Cf, Cytomegalovirus
510(k) Number K853989
Device Name COR DOT CMV
Applicant
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Applicant Contact SEYMOUR P HALBERT
Correspondent
Cordis Corp.
P.O. Box 025700
Miami,  FL  33102
Correspondent Contact SEYMOUR P HALBERT
Regulation Number866.3175
Classification Product Code
GQI  
Date Received09/27/1985
Decision Date 06/13/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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