NEUROLAC(R) NERVE GUIDE


Device Classification Name

cuff, nerve

510(k) Number K112267
Device Name NEUROLAC(R) NERVE GUIDE
Applicant
Polyganics BV
rozenburglaan 15a
groningen, 

NL

9727-dl

Applicant Contact betty ijmker
Correspondent
Polyganics BV
rozenburglaan 15a
groningen, 

NL

9727-dl

Correspodent Contact betty ijmker
Regulation Number 882.5275
Classification Product Code
JXI  
Date Received 08/08/2011
Decision Date 10/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No