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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 K921562
Device Name JOBST EXTREMITY PUMP SYSTEM 7500
Applicant
Jobst Institute, Inc.
Box 653
Toledo,  OH  43694
Applicant Contact ANGELO R PEREIRA
Correspondent
Jobst Institute, Inc.
Box 653
Toledo,  OH  43694
Correspondent Contact ANGELO R PEREIRA
Regulation Number870.5800
Classification Product Code
JOW  
Date Received04/01/1992
Decision Date 06/22/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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