510(k) K962377

3D-SPINE by Skill Technologies, Inc. — Product Code KQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1996
Date Received
June 20, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Goniometer, Ac-Powered
Device Class
Class I
Regulation Number
888.1500
Review Panel
NE
Submission Type