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FDA 510(k) Application Details - K994300
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K994300
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
DALE MEDICAL PRODUCTS, INC.
7 CROSS ST.
P.O. BOX 1556
PLAINVILLE, MA 02762 US
Other 510(k) Applications for this Company
Contact
JOHN C BREZACK
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
12/21/1999
Decision Date
02/10/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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