SAF-T-SHUNT, S-300 SERIES— 510(k) K892666

Name: FDA 510(k) clearance K892666
Creator: U.S. Food and Drug Administration
Published: 1989-05-04

Substantially Equivalent

Akcess Medical Products, Inc.

FDA 510(k) clearance K892666 for SAF-T-SHUNT, S-300 SERIES, Substantially Equivalent on 1989-05-04. Applicant: Akcess Medical Products, Inc.. Device class: 2.

Clearance details

Applicant: Akcess Medical Products, Inc.
Product code: Code FIQ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 1989-04-13
Decision date: 1989-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Brunswick, NJ, US

Download summary PDF View on FDA.gov ↗

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