510(k) K022217

AEU-425 TRANSPORT II PORTABLE DENTAL SYSTEM by Aseptico, Inc. — Product Code EIA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2002
Date Received
July 8, 2002
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