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FDA 510(k) Application Details - K192655
Device Classification Name
Plate, Bone
More FDA Info for this Device
510(K) Number
K192655
Device Name
Plate, Bone
Applicant
Synthes (USA) Products LLC
1301 Goshen Parkway
West Chester, PA 19380 US
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Contact
Satapa Dhamankar
Other 510(k) Applications for this Contact
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
09/25/2019
Decision Date
12/30/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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