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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Withdrawal/Infusion Pump
510(k) Number K902444
Device Name CLEARVIEW(TM) ANGIOSCOPIC IRRIGATION PUMP
Applicant
Intramed Laboratories, Inc.
11100 Roselle St.
San Diego,  CA  92121
Applicant Contact A SOSNOWSKI
Correspondent
Intramed Laboratories, Inc.
11100 Roselle St.
San Diego,  CA  92121
Correspondent Contact A SOSNOWSKI
Regulation Number870.1800
Classification Product Code
DQI  
Date Received06/01/1990
Decision Date 08/30/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
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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