FDA 510(k) Application Details - K040266

Device Classification Name Instrument, Biopsy

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510(K) Number K040266
Device Name Instrument, Biopsy
Applicant REMINGTON MEDICAL, INC.
6830 MEADOWRIDGE CT.
ALPHARETTA, GA 30005 US
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Contact MARIA P GRANITO
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Regulation Number 876.1075

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Classification Product Code KNW
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Date Received 02/05/2004
Decision Date 07/09/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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