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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 K050573
Device Name NEUROLAC NERVE GUIDE
Applicant
Polyganics BV
L.J. ZIELSTRAWEG 1
GRONINGEN,  NL 9713-GX
Applicant Contact JAN NIEUWENHUIS
Correspondent
Polyganics BV
L.J. ZIELSTRAWEG 1
GRONINGEN,  NL 9713-GX
Correspondent Contact JAN NIEUWENHUIS
Regulation Number882.5275
Classification Product Code
JXI  
Date Received03/07/2005
Decision Date 05/04/2005
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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