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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stabilizer, Heart, Non-Compression, Reprocessed
510(k) Number K070034
Device Name REPROCESSED GUIDANT CARDIAC STABILIZATION AND POSITIONING DEVICES
Applicant
Ascent Healthcare Solutions
10232 S. 51st St.
Phoenix,  AZ  85044
Applicant Contact KATIE BRAY
Correspondent
Ascent Healthcare Solutions
10232 S. 51st St.
Phoenix,  AZ  85044
Correspondent Contact KATIE BRAY
Regulation Number870.4500
Classification Product Code
NQG  
Date Received01/03/2007
Decision Date 08/17/2007
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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