EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA— 510(k) K852014

Name: FDA 510(k) clearance K852014
Creator: U.S. Food and Drug Administration
Published: 1985-08-07

Substantially Equivalent

Effner and Spreine Co.

FDA 510(k) clearance K852014 for EFFNER SIMS RECTAL SPECULUM W/FIBER OPTIC ILLUMINA, Substantially Equivalent on 1985-08-07. Applicant: Effner and Spreine Co.. Device class: 1.

Clearance details

Applicant: Effner and Spreine Co.
Product code: Code KOA
Device class: Class 1
Regulation: 21 CFR 876.4730
Advisory panel: Gastroenterology, Urology
Date received: 1985-05-09
Decision date: 1985-08-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Washington, NY, US

Download summary PDF View on FDA.gov ↗

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