510(k) K850803

NAIL SPLINT by Inro Medical Designs, Inc. — Product Code MQZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1985
Date Received
February 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Nail
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type