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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K063631
Device Name POLYPERF / POLYPERF SAFE
Applicant
Laboratoires Perouse
Rte. Du Manoir
Ivry Le Temple,  FR 60173
Applicant Contact MARIE NOELLE EROUT
Correspondent
Laboratoires Perouse
Rte. Du Manoir
Ivry Le Temple,  FR 60173
Correspondent Contact MARIE NOELLE EROUT
Regulation Number880.5440
Classification Product Code
FPA  
Subsequent Product Code
FMI  
Date Received12/06/2006
Decision Date 10/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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