L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)


Device Classification Name

stimulator, neuromuscular, external functional

510(k) Number K103343
Device Name L300 PLUS SYSTEM (RIGHT, LEFT), L300 PLUS SYSTEM UPGRADE KIT (RIGHT, LEFT)
Applicant
BIONESS INC.
25103 rye canyon loop
valencia, 
CA 
91355

Applicant Contact adele shoustal
Correspondent
BIONESS INC.
25103 rye canyon loop
valencia, 
CA 
91355

Correspodent Contact adele shoustal
Regulation Number 882.5810
Classification Product Code
GZI  
Subsequent Product Code
IPF  
Date Received 11/15/2010
Decision Date 04/29/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No