Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301

Prostate Immobilizer Rectal Balloon

Myriad Medical, LLC

The following data is part of a premarket notification filed by Myriad Medical, Llc with the FDA for Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301.

Pre-market Notification Details

Device IDK150234
510k NumberK150234
Device Name:Myriad Prostate Caddy¿ Immobilization Rectal Balloon Item #9901,3301
ClassificationProstate Immobilizer Rectal Balloon
Applicant Myriad Medical, LLC 2202 N..West Shore Blvd,Suite 200 Tampa,  FL  33607
ContactFrank Bimbo
CorrespondentFrank Bimbo
Myriad Medical, LLC 1535 Carrington Court Lawrenceville,  GA  30044
Product CodePCT  
CFR Regulation Number892.5720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-02
Decision Date2015-03-31
Summary:summary

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