510(k) K012505

SOPRO595 INTRA ORAL CAMERA by Sopro — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2001
Date Received
August 3, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Operative Dental
Device Class
Class I
Regulation Number
872.6640
Review Panel
DE
Submission Type