510(k) K111717

ELECTRO-GEL by Electro-Cap Intl., Inc. — Product Code GYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 2012
Date Received
June 20, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type