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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Counter-Pulsating, External
510(k) Number K022078
Device Name SOLA, COUNTER-PULSATION, MODEL SECP-S
Applicant
Sola Medical Devices, LLC
3722 Ave., Sausalito
Irvine,  CA  92606
Applicant Contact GREG HOLLAND
Correspondent
Sola Medical Devices, LLC
3722 Ave., Sausalito
Irvine,  CA  92606
Correspondent Contact GREG HOLLAND
Regulation Number870.5225
Classification Product Code
DRN  
Date Received06/26/2002
Decision Date 01/10/2003
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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