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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube, Aspirating, Flexible, Connecting
510(k) Number K853296
Device Name EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN
Applicant
Parexel Intl. Corp.
55 Wheeler St.
Cambridge,  MA  02138
Applicant Contact JULIAN P KAYE
Correspondent
Parexel Intl. Corp.
55 Wheeler St.
Cambridge,  MA  02138
Correspondent Contact JULIAN P KAYE
Regulation Number880.6740
Classification Product Code
BYY  
Date Received08/06/1985
Decision Date 08/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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