510(k) K013987

REPROCESSED DISPOSABLE TROCARS by Adven Medical — Product Code KBG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2002
Date Received
December 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar, Sinus
Device Class
Class I
Regulation Number
874.4420
Review Panel
EN
Submission Type