ELECTRO-GEL


Device Classification Name

media, electroconductive

510(k) Number K111717
Device Name ELECTRO-GEL
Applicant
ELECTRO-CAP INTL., INC.
1011 west lexington rd.
eaton, 
OH 
45320

Applicant Contact amy b swallows
Correspondent
ELECTRO-CAP INTL., INC.
1011 west lexington rd.
eaton, 
OH 
45320

Correspodent Contact amy b swallows
Regulation Number 882.1275
Classification Product Code
GYB  
Date Received 06/20/2011
Decision Date 01/05/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No