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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Compressor, Cardiac, External
510(k) Number K102068
Device Name MINIATURIZE CHEST COMPRESSOR (MCC)
Applicant
Resuscitation International
3722 Ave., Sausalito
Irvine,  CA  92606
Applicant Contact ROBYN SCOPIS
Correspondent
Resuscitation International
3722 Ave., Sausalito
Irvine,  CA  92606
Correspondent Contact ROBYN SCOPIS
Regulation Number870.5200
Classification Product Code
DRM  
Date Received07/23/2010
Decision Date 11/16/2010
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
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