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FDA 510(k) Application Details - K061677
Device Classification Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
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510(K) Number
K061677
Device Name
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant
HOWMEDICA OSTEONICS CORP
325 CORPORATE DR.
MAHWAH, NJ 07430 US
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TIFFANI ROGERS
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Regulation Number
888.3690
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Classification Product Code
HSD
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Date Received
06/15/2006
Decision Date
07/10/2006
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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