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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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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