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FDA 510(k) Application Details - K982894
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K982894
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
BALLARD MEDICAL PRODUCTS
12050 LONE PEAK PKWY.
DRAPER, UT 84020 US
Other 510(k) Applications for this Company
Contact
E. MARTIN CHAMBERLAIN
Other 510(k) Applications for this Contact
Regulation Number
876.5980
More FDA Info for this Regulation Number
Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/17/1998
Decision Date
09/11/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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