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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lavage, jet
510(k) Number K983135
Device Name BLOWER/MISTER
Applicant
CARDIOTHORACIC SYSTEMS, INC.
10600 NORTH TANTAU AVE.
CUPERTINO,  CA  95014
Applicant Contact MIKE BILLIG
Correspondent
CARDIOTHORACIC SYSTEMS, INC.
10600 NORTH TANTAU AVE.
CUPERTINO,  CA  95014
Correspondent Contact MIKE BILLIG
Regulation Number880.5475
Classification Product Code
FQH  
Date Received09/08/1998
Decision Date 11/13/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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