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FDA 510(k) Application Details - K993200
Device Classification Name
Subsystem, Water Purification
More FDA Info for this Device
510(K) Number
K993200
Device Name
Subsystem, Water Purification
Applicant
ISOPURE CORP.
11700 COMMONWEALTH DR.
SUITE 605
LOUISVILLE, KY 40299 US
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Contact
KEVIN C GILLESPIE
Other 510(k) Applications for this Contact
Regulation Number
876.5665
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Classification Product Code
FIP
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More FDA Info for this Product Code
Date Received
09/24/1999
Decision Date
01/24/2000
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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