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FDA 510(k) Application Details - K040128
Device Classification Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
More FDA Info for this Device
510(K) Number
K040128
Device Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH, NJ 07430 US
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Contact
MARGARET F CROWE
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Regulation Number
888.3690
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Classification Product Code
HSD
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More FDA Info for this Product Code
Date Received
01/21/2004
Decision Date
03/26/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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