510(k) K941342

PAIN DOC by Regulatory & Marketing Services, Inc. — Product Code GZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1995
Date Received
February 22, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device Class
Class II
Regulation Number
882.5880
Review Panel
NE
Submission Type