510(k) K993306

NIKOPAD ELECTROSURGICAL GROUNDING PAD (*OR SOLD UNDER COMMERCIAL NAMES), MODEL 4760 (TYPICALLY) by Paladin Medical, Inc. — Product Code HAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1999
Date Received
October 4, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Electrosurgical
Device Class
Class II
Regulation Number
878.4400
Review Panel
SU
Submission Type