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FDA 510(k) Application Details - K961607
Device Classification Name
Accessories, Cleaning, For Endoscope
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
FEB
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More FDA Info for this Product Code
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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