Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301— 510(k) K150234

Name: FDA 510(k) clearance K150234
Creator: U.S. Food and Drug Administration
Published: 2015-03-31

Substantially Equivalent

Myriad Medical, LLC

FDA 510(k) clearance K150234 for Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301, Substantially Equivalent on 2015-03-31. Applicant: Myriad Medical, LLC. Device class: 2.

Clearance details

Applicant: Myriad Medical, LLC
Product code: Code PCT
Device class: Class 2
Regulation: 21 CFR 892.5720
Advisory panel: Radiology
Date received: 2015-02-02
Decision date: 2015-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Download summary PDF View on FDA.gov ↗

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