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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessory Equipment, Cardiopulmonary Bypass
510(k) Number K892856
Device Name NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS
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 Number870.4200
Classification Product Code
KRI  
Date Received04/18/1989
Decision Date 11/08/1989
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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