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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K901619
Device Name WEX MULTI DOMAIN CARDIAC SYSTEM (HD-3L)
Applicant
Wex Medical Instrumentation Co.
175-01 Rockaway Blvd.
Suite 211a
Jamaica,  NY  11434
Applicant Contact RICHARD S PECORA
Correspondent
Wex Medical Instrumentation Co.
175-01 Rockaway Blvd.
Suite 211a
Jamaica,  NY  11434
Correspondent Contact RICHARD S PECORA
Classification Product Code
LOS
Date Received04/06/1990
Decision Date 09/05/1991
Decision Substantially Equivalent (SESE)
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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