510(k) K936068

ORTHOPHOS 3/ ORTHOPHOS 3C by Pelton & Crane Co. — Product Code EAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1994
Date Received
December 21, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, X-Ray, Intraoral
Device Class
Class II
Regulation Number
872.1810
Review Panel
RA
Submission Type