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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 K032852
Device Name MODIFICATION TO: AUTOPULSE RESUSCITATION SYSTEM MODEL 100
Applicant
Revivant Corp.
775 Palomar Ave.
Sunnyvale,  CA  94085
Applicant Contact BOB H KATZ
Correspondent
Revivant Corp.
775 Palomar Ave.
Sunnyvale,  CA  94085
Correspondent Contact BOB H KATZ
Regulation Number870.5200
Classification Product Code
DRM  
Date Received09/12/2003
Decision Date 11/12/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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