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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Human Lyophilized Dura Mater
510(k) Number K910555
Device Name TUTOPLAST DURA
Applicant
Pfrimmer-Viggo GmbH & Co.
C/O Kleinfeld, Kaplan & Becker
1140 Nineteenth St., NW
Washington,  DC  20036
Applicant Contact ALAN H KAPLAN
Correspondent
Pfrimmer-Viggo GmbH & Co.
C/O Kleinfeld, Kaplan & Becker
1140 Nineteenth St., NW
Washington,  DC  20036
Correspondent Contact ALAN H KAPLAN
Classification Product Code
LEM  
Date Received02/07/1991
Decision Date 04/20/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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