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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hypothermia, Intravenous, Cooling
510(k) Number K101987
Device Name COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593
Applicant
ZOLL CIRCULATION
650 ALMANOR AVENUE
SUNNYVALE,  CA  94085
Applicant Contact SAM NANAVATI
Correspondent
ZOLL CIRCULATION
650 ALMANOR AVENUE
SUNNYVALE,  CA  94085
Correspondent Contact SAM NANAVATI
Regulation Number870.5900
Classification Product Code
NCX  
Date Received07/14/2010
Decision Date 10/12/2010
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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