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FDA 510(k) Application Details - K121574
Device Classification Name
Plate, Bone
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510(K) Number
K121574
Device Name
Plate, Bone
Applicant
SYNTHES INC
1301 Goshen Parkway
West Chester, PA 19380 US
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Contact
ALAN T HALEY
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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
05/30/2012
Decision Date
06/29/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
DE - Dental
Review Advisory Committee
DE - Dental
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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