510(k) K030895

ASEPTICO ENDOPEX V, MODEL AEU-40 by Aseptico, Inc. — Product Code LQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 2003
Date Received
March 21, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Locator, Root Apex
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type