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FDA 510(k) Application Details - K142201
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
More FDA Info for this Device
510(K) Number
K142201
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant
OMNLIFE SCIENCE
50 O'CONNELL WAY
SUITE 10
EAST TAUNTON, MA 02718 US
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Contact
Vani Sindwani
Other 510(k) Applications for this Contact
Regulation Number
888.3358
More FDA Info for this Regulation Number
Classification Product Code
LPH
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More FDA Info for this Product Code
Date Received
08/11/2014
Decision Date
01/26/2015
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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