510(k) K030887

LEKTROGEL, MODEL LK3001 by Inmed Ltda. — Product Code GYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 13, 2003
Date Received
March 21, 2003
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