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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 K011046
Device Name AUTOPULSE, MODEL 100
Applicant
REVIVANT CORP.
775 PALOMAR
SUNNYVALE,  CA  94085
Applicant Contact BOB KATZ
Correspondent
REVIVANT CORP.
775 PALOMAR
SUNNYVALE,  CA  94085
Correspondent Contact BOB KATZ
Regulation Number870.5200
Classification Product Code
DRM  
Date Received04/06/2001
Decision Date 10/25/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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