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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 K982401
Device Name PROSTATE BIOPSY NEEDLE
Applicant
REMINGTON MEDICAL, INC.
6830 MEADOWRIDGE CT.
ALPHARETTA,  GA  30005
Applicant Contact STEVE WOODY
Correspondent
REMINGTON MEDICAL, INC.
6830 MEADOWRIDGE CT.
ALPHARETTA,  GA  30005
Correspondent Contact STEVE WOODY
Regulation Number876.1075
Classification Product Code
KNW  
Date Received07/10/1998
Decision Date 09/08/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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