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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, biopsy
510(k) Number K130282
Device Name REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
Original Applicant
REMINGTON MEDICAL, INC.
6830 meadowridge ct.
alpharetta,  GA  30005
Original Contact caitlin senter, ms, rac
Regulation Number876.1075
Classification Product Code
KNW  
Date Received02/05/2013
Decision Date 05/13/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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