MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM— 510(k) K000444

Name: FDA 510(k) clearance K000444
Creator: U.S. Food and Drug Administration
Published: 2000-04-21

Substantially Equivalent

Prism Enterprises, Inc.

FDA 510(k) clearance K000444 for MITYVIEW 4-WAY LATERAL EXPANDER SPECULUM, Substantially Equivalent on 2000-04-21. Applicant: Prism Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Prism Enterprises, Inc.
Product code: Code HIB
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2000-02-10
Decision date: 2000-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, 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.