FEMTEN CERVICAL TENACULUM— 510(k) K062563

Substantially Equivalent

Fem Suite, LLC

FDA 510(k) clearance K062563 for FEMTEN CERVICAL TENACULUM, Substantially Equivalent on 2007-05-18. Applicant: Fem Suite, LLC. Device class: 2.

Clearance details

Applicant: Fem Suite, LLC
Product code: Code HDC
Device class: Class 2
Regulation: 21 CFR 884.4530
Advisory panel: Obstetrics/Gynecology
Date received: 2006-08-31
Decision date: 2007-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Port Townsend, WA, 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.