TRANSENDOSCOPIC INJECTION CATHETER TEI— 510(k) K821336

Name: FDA 510(k) clearance K821336
Creator: U.S. Food and Drug Administration
Published: 1982-05-21

Substantially Equivalent

Sounson Research Co., Inc.

FDA 510(k) clearance K821336 for TRANSENDOSCOPIC INJECTION CATHETER TEI, Substantially Equivalent on 1982-05-21. Applicant: Sounson Research Co., Inc.. Device class: 2.

Clearance details

Applicant: Sounson Research Co., Inc.
Product code: Code KNY
Device class: Class 2
Regulation: 21 CFR 876.5130
Advisory panel: Gastroenterology, Urology
Date received: 1982-05-05
Decision date: 1982-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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