FDA 510(k) Application Details - K961607

Device Classification Name Accessories, Cleaning, For Endoscope

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510(K) Number K961607
Device Name Accessories, Cleaning, For Endoscope
Applicant VIATRO, CORP.
6779 ENGLE RD.
CLEVELAND, OH 44130 US
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Contact JAN J LEWANDOWSKI
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Regulation Number 876.1500

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Classification Product Code FEB
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Date Received 04/25/1996
Decision Date 12/06/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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