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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dura Substitute
510(k) Number K982101
Device Name SHELHIGH NO-REACT DURA SHIELD
Applicant
Shelhigh, Inc.
P.O. Box 884
Millburn,  NJ  07041
Applicant Contact SHLOMO GABBAY
Correspondent
Shelhigh, Inc.
P.O. Box 884
Millburn,  NJ  07041
Correspondent Contact SHLOMO GABBAY
Regulation Number882.5910
Classification Product Code
GXQ  
Date Received06/15/1998
Decision Date 05/02/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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