KODNER ANAL PERIONEAL RETRACTOR— 510(k) K870897

Name: FDA 510(k) clearance K870897
Creator: U.S. Food and Drug Administration
Published: 1987-06-04

Substantially Equivalent

Sur-Med Instruments, Inc.

FDA 510(k) clearance K870897 for KODNER ANAL PERIONEAL RETRACTOR, Substantially Equivalent on 1987-06-04. Applicant: Sur-Med Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Sur-Med Instruments, Inc.
Product code: Code FFO
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1987-03-05
Decision date: 1987-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

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