FDA 510(k) Application Details - K955717

Device Classification Name Laparoscopy Kit

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510(K) Number K955717
Device Name Laparoscopy Kit
Applicant MITSUBISHI CABLE AMERICA, INC.
10551 WULFF DR.
ORANGE, CA 92667 US
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Contact RONALD J EHMSEN
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Regulation Number 876.1500

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Classification Product Code FDE
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Date Received 12/18/1995
Decision Date 04/18/1996
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 N
Expedited Review



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