510(k) K980804

SABRE BT BLUNT0TIP SURGICAL TROCAR by Endoscopic Concepts, Inc. — Product Code FBQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 1, 1998
Date Received
March 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Trocar, Gastro-Urology
Device Class
Class II
Regulation Number
876.5090
Review Panel
SU
Submission Type