KSEA RIGID CULDOSCOPE AND ACCESSORIES— 510(k) K993804

Name: FDA 510(k) clearance K993804
Creator: U.S. Food and Drug Administration
Published: 2000-02-07

Substantially Equivalent

KARL STORZ Endoscopy-America, Inc.

FDA 510(k) clearance K993804 for KSEA RIGID CULDOSCOPE AND ACCESSORIES, Substantially Equivalent on 2000-02-07. Applicant: KARL STORZ Endoscopy-America, Inc.. Device class: 2.

Clearance details

Applicant: KARL STORZ Endoscopy-America, Inc.
Product code: Code HEW
Device class: Class 2
Regulation: 21 CFR 884.1640
Advisory panel: Obstetrics/Gynecology
Date received: 1999-11-09
Decision date: 2000-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.