510(k) K051751

EQUA-PULL SAFETY RELEASE MODULE by Ortho Technology — Product Code DZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2005
Date Received
June 29, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Headgear, Extraoral, Orthodontic
Device Class
Class II
Regulation Number
872.5500
Review Panel
DE
Submission Type