FDA 510(k) Application Details - K032092

Device Classification Name Forceps, Biopsy, Non-Electric

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510(K) Number K032092
Device Name Forceps, Biopsy, Non-Electric
Applicant OLYMPUS OPTICAL CO., LTD.
34-3 HIRAI HINODE-MACHI,
NISHITIMA-GUN, TOKYO 190-0182 JP
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Contact MASAO WADA
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Regulation Number 876.1075

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Classification Product Code FCL
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Date Received 07/07/2003
Decision Date 07/16/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party Y
Expedited Review



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