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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 K071040
Device Name WRIGHT MODEL 51 AND 52 SEQUENTIAL COMPRESSION SYSTEMS
Applicant
Wright Linear Pump, Inc.
103-B International Dr.
Oakdale,  PA  15071
Applicant Contact CAROL WRIGHT
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/12/2007
Decision Date 05/22/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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