510(k) K030163

ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 by Aseptico, Inc. — Product Code EKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 2003
Date Received
January 16, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Handpiece, Direct Drive, Ac-Powered
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type