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FDA 510(k) Application Details - K191997
Device Classification Name
Plate, Bone
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510(K) Number
K191997
Device Name
Plate, Bone
Applicant
FAICO Medical LLC
9689 Parkview Ave.
Boca Raton, FL 33428 US
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Contact
Heman Dario Fernandez
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Regulation Number
872.4760
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Classification Product Code
JEY
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More FDA Info for this Product Code
Date Received
07/26/2019
Decision Date
04/22/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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