SAVI PREPARATION DEVICE

System, Applicator, Radionuclide, Remote-controlled

CIANNA MEDICAL, INC.

The following data is part of a premarket notification filed by Cianna Medical, Inc. with the FDA for Savi Preparation Device.

Pre-market Notification Details

Device IDK101411
510k NumberK101411
Device Name:SAVI PREPARATION DEVICE
ClassificationSystem, Applicator, Radionuclide, Remote-controlled
Applicant CIANNA MEDICAL, INC. 6 JOURNEY SUITE 125 Aliso Viejo,  CA  92656
ContactGary Mocnik
CorrespondentGary Mocnik
CIANNA MEDICAL, INC. 6 JOURNEY SUITE 125 Aliso Viejo,  CA  92656
Product CodeJAQ  
CFR Regulation Number892.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-05-19
Decision Date2010-07-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884450433928 K101411 000
00884450433904 K101411 000

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