PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR— 510(k) K862107

Name: FDA 510(k) clearance K862107
Creator: U.S. Food and Drug Administration
Published: 1986-09-11

Substantially Equivalent

Penn Medical Devices, Inc.

FDA 510(k) clearance K862107 for PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR, Substantially Equivalent on 1986-09-11. Applicant: Penn Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Penn Medical Devices, Inc.
Product code: Code ODC
Device class: Class 2
Regulation: 21 CFR 876.1500
Advisory panel: Gastroenterology, Urology
Date received: 1986-06-03
Decision date: 1986-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Basking Ridge, NJ, US

Download summary PDF View on FDA.gov ↗

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