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FDA 510(k) Application Details - K042018
Device Classification Name
Subsystem, Water Purification
More FDA Info for this Device
510(K) Number
K042018
Device Name
Subsystem, Water Purification
Applicant
SIMPLY CLEAN AIR & WATER, INC.
28 SHEPARD DRIVE
NEWINGTON, CT 06131 US
Other 510(k) Applications for this Company
Contact
RAYMOND KOWALEC
Other 510(k) Applications for this Contact
Regulation Number
876.5665
More FDA Info for this Regulation Number
Classification Product Code
FIP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/27/2004
Decision Date
04/15/2005
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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