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FDA 510(k) Application Details - K190414
Device Classification Name
More FDA Info for this Device
510(K) Number
K190414
Device Name
Moss Gastrostomy Tube, Moss Nasal Tube û Mark IV
Applicant
Moss Tubes, Inc.
1929 Route 9
Castleton on Hudson, NY 12033 US
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Contact
Michael Moss
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Regulation Number
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Classification Product Code
PIF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/21/2019
Decision Date
06/14/2019
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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