OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT— 510(k) K864623

Name: FDA 510(k) clearance K864623
Creator: U.S. Food and Drug Administration
Published: 1987-01-14

Substantially Equivalent

Xanmed Corp.

FDA 510(k) clearance K864623 for OBSTETRICAL/GYNECOLOGICAL CUSTOM SURGICAL KIT, Substantially Equivalent on 1987-01-14. Applicant: Xanmed Corp.. Device class: 2.

Clearance details

Applicant: Xanmed Corp.
Product code: Code KNA
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 1986-11-25
Decision date: 1987-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Central Islip, NY, US

Download summary PDF View on FDA.gov ↗

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