SABRE BT BLUNT0TIP SURGICAL TROCAR— 510(k) K980804

Name: FDA 510(k) clearance K980804
Creator: U.S. Food and Drug Administration
Published: 1998-04-01

Substantially Equivalent

Endoscopic Concepts, Inc.

FDA 510(k) clearance K980804 for SABRE BT BLUNT0TIP SURGICAL TROCAR, Substantially Equivalent on 1998-04-01. Applicant: Endoscopic Concepts, Inc.. Device class: 2.

Clearance details

Applicant: Endoscopic Concepts, Inc.
Product code: Code FBQ
Device class: Class 2
Regulation: 21 CFR 876.5090
Advisory panel: Gastroenterology, Urology
Date received: 1998-03-02
Decision date: 1998-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pawtucket, RI, US

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