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FDA 510(k) Application Details - K040110
Device Classification Name
Rod, Colostomy
More FDA Info for this Device
510(K) Number
K040110
Device Name
Rod, Colostomy
Applicant
TOOLS FOR SURGERY, LLC
1339 STONY BROOK ROAD
STONY BROOK, NY 11790 US
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Contact
ARNOLD R LEIBOFF
Other 510(k) Applications for this Contact
Regulation Number
876.4270
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Classification Product Code
EZP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/20/2004
Decision Date
03/24/2004
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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