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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manometer, Blood-Pressure, Venous
510(k) Number K884386
Device Name ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK
Applicant
Ethitek Pharmaceuticals Co.
8100 N. Lawndale Ave.
Skokie,  IL  60076
Applicant Contact LIONEL N SIMON
Correspondent
Ethitek Pharmaceuticals Co.
8100 N. Lawndale Ave.
Skokie,  IL  60076
Correspondent Contact LIONEL N SIMON
Regulation Number870.1140
Classification Product Code
KRK  
Date Received10/18/1988
Decision Date 01/05/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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