FDA 510(k) Application Details - K915596

Device Classification Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

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510(K) Number K915596
Device Name Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Applicant BIOMET, INC.
P.O. BOX 587
AIRPORT INDUSTRIAL PARK
WARSAW, IN US
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Contact PATRICIA BERES
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Regulation Number 888.3650

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Classification Product Code KWT
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Date Received 12/13/1991
Decision Date 03/11/1992
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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