FDA 510(k) Application Details - K984255

Device Classification Name Ligator, Esophageal

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510(K) Number K984255
Device Name Ligator, Esophageal
Applicant OLYMPUS CORP OF AMERICA
4 NEVADA DR.
LAKE SUCCESS, NY 11042-1179 US
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Contact LAURA STORMS-TYLER
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Regulation Number 876.4400

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Classification Product Code MND
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Date Received 11/30/1998
Decision Date 01/12/1999
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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