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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instruments, Surgical, Cardiovascular
510(k) Number K892804
Device Name NEWCHILL(TM) CARDIAC INSULATOR
Applicant
Acacia Laboratories, Inc.
1010 Hathaway Ave.
Santa Ana,  CA  92705
Applicant Contact WILLIAM A GOOLSBEE
Correspondent
Acacia Laboratories, Inc.
1010 Hathaway Ave.
Santa Ana,  CA  92705
Correspondent Contact WILLIAM A GOOLSBEE
Regulation Number870.4500
Classification Product Code
DWS  
Date Received04/17/1989
Decision Date 07/14/1989
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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