510(k) K022823

VALVULOTOME, RETROGRADE : 03-7500- 03-7510, ANTEGRADE 03-7520 by Geister Medizin Technik GmbH — Product Code MGZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2004
Date Received
August 26, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valvulotome
Device Class
Class II
Regulation Number
870.4885
Review Panel
CV
Submission Type