SUR-FIT IRRIGATION SLEEVE— 510(k) K811160

Name: FDA 510(k) clearance K811160
Creator: U.S. Food and Drug Administration
Published: 1981-06-02

Substantially Equivalent

E. R. Squibb & Sons, Inc.

FDA 510(k) clearance K811160 for SUR-FIT IRRIGATION SLEEVE, Substantially Equivalent on 1981-06-02. Applicant: E. R. Squibb & Sons, Inc.. Device class: 2.

Clearance details

Applicant: E. R. Squibb & Sons, Inc.
Product code: Code EXD
Device class: Class 2
Regulation: 21 CFR 876.5895
Advisory panel: Gastroenterology, Urology
Date received: 1981-04-28
Decision date: 1981-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

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