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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name prostate immobilizer rectal balloon
510(k) Number K150234
Device Name Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301
Myriad Medical, LLC
2202 N..West Shore Blvd,Suite 200
Tampa,  FL  33607
Applicant Contact Frank Bimbo
Myriad Medical, LLC
1535 Carrington Court
Lawrenceville,  GA  30044
Correspondent Contact Frank Bimbo
Regulation Number892.5720
Classification Product Code
Date Received02/02/2015
Decision Date 03/31/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No