FDA 510(k) Application Details - K990687

Device Classification Name

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510(K) Number K990687
Device Name HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS
Applicant OLYMPUS OPTICAL, CO.
2 CORPORATE CENTER
MELVILLE, NY 11747 US
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Contact LAURA STORMS TYLER
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Regulation Number

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Classification Product Code PKL
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Date Received 03/01/1999
Decision Date 03/26/1999
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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