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FDA 510(k) Application Details - K171904
Device Classification Name
Plate, Fixation, Bone
More FDA Info for this Device
510(K) Number
K171904
Device Name
Plate, Fixation, Bone
Applicant
Microware Precision Co., Ltd.
No. 12, Keyuan 2nd Rd.,
Situn District
Taichung 407630 TW
Other 510(k) Applications for this Company
Contact
Harrison Du
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
06/26/2017
Decision Date
09/18/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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