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FDA 510(k) Application Details - K022826
Device Classification Name
Anti Fog Solution And Accessories, Endoscopy
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510(K) Number
K022826
Device Name
Anti Fog Solution And Accessories, Endoscopy
Applicant
PRESERVATION SOLUTIONS, INC.
8300 W. 110TH ST.
BLOOMINGTON, MN 55438 US
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Contact
JOHN R DALPEE
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Regulation Number
876.1500
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Classification Product Code
OCT
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More FDA Info for this Product Code
Date Received
08/26/2002
Decision Date
10/09/2002
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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