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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 -3907
Applicant Contact CAROL WRIGHT
Correspondent
CITECH
5200 BUTLER PIKE
PLYMOUTH MEETING,  PA  19462 -1298
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
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