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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mesh, surgical
510(k) Number K091499
FOIA Releasable 510(k) K091499
Device Name MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY)
Applicant
KENSEY NASH CORP.
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Applicant Contact Alyssa Schwartz
Correspondent
KENSEY NASH CORP.
735 PENNSYLVANIA DRIVE
EXTON,  PA  19341
Correspondent Contact Alyssa Schwartz
Regulation Number878.3300
Classification Product Code
FTM  
Subsequent Product Codes
OWY   OXB   OXE   OXH   PAJ  
Date Received05/21/2009
Decision Date 10/22/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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