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FDA 510(k) Application Details - K070449
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K070449
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
SPECIALIZED HEALTH PRODUCTS INTERNATIONAL, INC.
586 WEST 500 SOUTH #200
SALT LAKE, UT 84010 US
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Contact
Mark Nelson
Other 510(k) Applications for this Contact
Regulation Number
876.5980
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Classification Product Code
KNT
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More FDA Info for this Product Code
Date Received
02/15/2007
Decision Date
06/14/2007
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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