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FDA 510(k) Application Details - K022377
Device Classification Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
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510(K) Number
K022377
Device Name
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Applicant
IMPLEX CORP.
80 COMMERCE DR.
ALLENDALE, NJ 07401-1600 US
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Contact
ROBERT A POGGIE
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Regulation Number
888.3650
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Classification Product Code
KWT
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More FDA Info for this Product Code
Date Received
07/22/2002
Decision Date
12/10/2002
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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