NEUROLAC(R) NERVE GUIDE— 510(k) K112267

Substantially Equivalent

Polyganics B.V.,

FDA 510(k) clearance K112267 for NEUROLAC(R) NERVE GUIDE, Substantially Equivalent on 2011-10-20. Applicant: Polyganics B.V.,. Device class: 2.

Clearance details

Applicant
Polyganics B.V.,
Product code
Code JXI
Device class
Class 2
Regulation
21 CFR 882.5275
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Groningen, NL
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