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FDA 510(k) Application Details - K193305
Device Classification Name
Staple, Fixation, Bone
More FDA Info for this Device
510(K) Number
K193305
Device Name
Staple, Fixation, Bone
Applicant
MedShape, Inc.
1575 Northside Drive NW, Suite 440
Atlanta, GA 30318 US
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Contact
Jack Griffis
Other 510(k) Applications for this Contact
Regulation Number
888.3030
More FDA Info for this Regulation Number
Classification Product Code
JDR
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More FDA Info for this Product Code
Date Received
11/29/2019
Decision Date
04/23/2020
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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