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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
Recalls CDRH Recalls
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