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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cuff, Nerve
510(k) Number K983007
Device Name NEUROTUBE
Applicant
NEUROREGEN, L.L.C.
43 N. BONDS ST.
BEL AIR,  MD  21014
Applicant Contact JOHN E BARHAM
Correspondent
NEUROREGEN, L.L.C.
43 N. BONDS ST.
BEL AIR,  MD  21014
Correspondent Contact JOHN E BARHAM
Regulation Number882.5275
Classification Product Code
JXI  
Date Received08/28/1998
Decision Date 03/22/1999
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
Recalls CDRH Recalls
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