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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 K954788
Device Name EUREDUC PNEUMATIC DRAINAGE SYSTEM
Applicant
Eureduc
5, Ave. Residence
Antony,  FR 92160
Applicant Contact PHILIPPE JOUBERT
Correspondent
Eureduc
5, Ave. Residence
Antony,  FR 92160
Correspondent Contact PHILIPPE JOUBERT
Regulation Number870.5800
Classification Product Code
JOW  
Date Received10/18/1995
Decision Date 10/28/1996
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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