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FDA 510(k) Application Details - K043346
Device Classification Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
More FDA Info for this Device
510(K) Number
K043346
Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Applicant
GENESIS MEDICAL L.L.C.
2650 US HIGHWAY 130
CRANBURY, NJ 08512 US
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Contact
PERRY GEREMAKIS
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Regulation Number
888.3660
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Classification Product Code
KWS
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More FDA Info for this Product Code
Date Received
12/06/2004
Decision Date
01/31/2005
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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