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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sleeve, Limb, Compressible
510(k) Number K123308
Device Name PULSTAR LOGIX INTERMITTENT PNEUMATIC COMPRESSION SYSTEM
Applicant
Albahealth, LLC
425 N Gateway Ave.
Rockwood,  TN  37854
Applicant Contact PATRICK FRANK
Correspondent
Albahealth, LLC
425 N Gateway Ave.
Rockwood,  TN  37854
Correspondent Contact PATRICK FRANK
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/24/2012
Decision Date 02/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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