OPEN BREAST COIL (OBC) WITH BIOPSY PLATES

Coil, Magnetic Resonance, Specialty

USA INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Usa Instruments, Inc. with the FDA for Open Breast Coil (obc) With Biopsy Plates.

Pre-market Notification Details

Device IDK050728
510k NumberK050728
Device Name:OPEN BREAST COIL (OBC) WITH BIOPSY PLATES
ClassificationCoil, Magnetic Resonance, Specialty
Applicant USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora,  OH  44202
ContactDavid Brown
CorrespondentDavid Brown
USA INSTRUMENTS, INC. 1515 DANNER DR. Aurora,  OH  44202
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-21
Decision Date2005-06-28
Summary:summary

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