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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K133030
Device Name DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)
Applicant
INVIVO CORPORATION
3545 SW 47TH AVE.
GAINESVILLE,  FL  32608
Applicant Contact Lisa Simpson
Correspondent
INVIVO CORPORATION
3545 SW 47TH AVE.
GAINESVILLE,  FL  32608
Correspondent Contact Lisa Simpson
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received09/26/2013
Decision Date 01/22/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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