MODIFICATION TO:NESS L300


Device Classification Name

stimulator, neuromuscular, external functional

510(k) Number K080219
Device Name MODIFICATION TO:NESS L300
Applicant
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
25103 rye canyon loop
valencia, 
CA 
91355

Applicant Contact evan rosenfeld
Correspondent
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS
25103 rye canyon loop
valencia, 
CA 
91355

Correspodent Contact evan rosenfeld
Regulation Number 882.5810
Classification Product Code
GZI  
Date Received 01/29/2008
Decision Date 02/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No