510(k) K853635

SUBDERM TM by General Medical Co. — Product Code EGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1985
Date Received
August 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Iontophoresis, Other Uses
Device Class
Class II
Regulation Number
890.5525
Review Panel
PM
Submission Type