ALATUS VAGINAL BALLOON PACKING SYSTEM— 510(k) K092534

Name: FDA 510(k) clearance K092534
Creator: U.S. Food and Drug Administration
Published: 2009-12-07

Substantially Equivalent

Radiadyne

FDA 510(k) clearance K092534 for ALATUS VAGINAL BALLOON PACKING SYSTEM, Substantially Equivalent on 2009-12-07. Applicant: Radiadyne. Device class: 2.

Clearance details

Applicant: Radiadyne
Product code: Code JAQ
Device class: Class 2
Regulation: 21 CFR 892.5700
Advisory panel: Radiology
Date received: 2009-08-19
Decision date: 2009-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, 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.