FDA 510(k) Application Details - K992006

Device Classification Name Endoscope Holder

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510(K) Number K992006
Device Name Endoscope Holder
Applicant INTEGRA NEUROCARE LLC.
5955 PACIFIC CENTER BLVD.
SAN DIEGO, CA 92121 US
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Contact NANCY A MATHEWSON
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Regulation Number 876.1500

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Classification Product Code OCV
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Date Received 06/15/1999
Decision Date 08/17/1999
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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