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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
Recalls CDRH Recalls
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