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FDA 510(k) Application Details - K973893
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K973893
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
APPLIED MEDICAL TECHNOLOGIES
15653 NEO PKWY.
CLEVELAND, OH 44128-3150 US
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Contact
THOMAS W PARKINSON
Other 510(k) Applications for this Contact
Regulation Number
876.5980
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Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/14/1997
Decision Date
12/19/1997
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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