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FDA 510(k) Application Details - K111611
Device Classification Name
Prosthesis, Esophageal
More FDA Info for this Device
510(K) Number
K111611
Device Name
Prosthesis, Esophageal
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PKWY.
SOUTH JORDAN, UT 84095-2415 US
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Contact
JOHN C KNORPP
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Regulation Number
878.3610
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Classification Product Code
ESW
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More FDA Info for this Product Code
Date Received
06/09/2011
Decision Date
07/29/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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