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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sucker, Cardiotomy Return, Cardiopulmonary Bypass
510(k) Number K982891
Device Name CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDS
Applicant
California Medical Laboratories, Inc.
2681 Kelvin Ave.
Irvine,  CA  92614
Applicant Contact MEHMET BICAKCI
Correspondent
California Medical Laboratories, Inc.
2681 Kelvin Ave.
Irvine,  CA  92614
Correspondent Contact MEHMET BICAKCI
Regulation Number870.4420
Classification Product Code
DTS  
Date Received08/17/1998
Decision Date 09/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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