HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER— 510(k) K862949

Name: FDA 510(k) clearance K862949
Creator: U.S. Food and Drug Administration
Published: 1986-10-31

Substantially Equivalent

Oscor Medical Corp.

FDA 510(k) clearance K862949 for HATCHER STONE EXTRACTOR - DISPOSABLE CATHETER, Substantially Equivalent on 1986-10-31. Applicant: Oscor Medical Corp.. Device class: 2.

Clearance details

Applicant: Oscor Medical Corp.
Product code: Code LQR
Device class: Class 2
Regulation: 21 CFR 876.5010
Advisory panel: Gastroenterology, Urology
Date received: 1986-08-05
Decision date: 1986-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palm Harbor, FL, US

Download summary PDF View on FDA.gov ↗

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