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FDA 510(k) Application Details - K190365
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K190365
Device Name
Plate, Fixation, Bone
Applicant
Paragon 28, Inc.
4B Inverness Ct. E, STE 280
Englewood, CO 80112 US
Other 510(k) Applications for this Company
Contact
Eric Lintula
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
HRS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/15/2019
Decision Date
04/12/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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