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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 BV
L.J. ZIELSTRAWEG 1
GRONINGEN,  NL 9713-GX
Applicant Contact JAN BART HAK
Correspondent
Polyganics BV
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
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