510(k) K861470

#CTO 100 (CERVICAL TRACTION ORTHOSIS 100) by Applied Medical Systems — Product Code HAX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1986
Date Received
April 22, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tong, Skull For Traction
Device Class
Class II
Regulation Number
882.5960
Review Panel
NE
Submission Type