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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 K032115
FOIA Releasable 510(k) K032115
Device Name NEUROLAC NERVE GUIDE MODELS NG01-15/03, NG01-020/03, NG01 025/03, NG01-030/03
Applicant
Polyganics B.V.,
L.J. Zielstraweg 1
Groningen,  NL 9713-GX
Applicant Contact JAN BART HAK
Correspondent
Polyganics B.V.,
L.J. Zielstraweg 1
Groningen,  NL 9713-GX
Correspondent Contact JAN BART HAK
Regulation Number882.5275
Classification Product Code
JXI  
Date Received07/09/2003
Decision Date 10/10/2003
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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