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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 K910447
Device Name DURA MATER
Applicant
Lifelink Foundation Tissue Bank
8510 Sunstate St.
Tampa,  FL  33634
Applicant Contact DAVE SHIRES
Correspondent
Lifelink Foundation Tissue Bank
8510 Sunstate St.
Tampa,  FL  33634
Correspondent Contact DAVE SHIRES
Classification Product Code
LEM  
Date Received01/18/1991
Decision Date 06/09/1992
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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