FDA 510(k) Application Details - K935185

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

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510(K) Number K935185
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Applicant LANDOS, INC.
301 LINDENWOOD DR.
SUITE ONE
MALVERN, PA US
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Contact HENRY P FERRET
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Regulation Number 888.3353

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Classification Product Code LZO
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Date Received 10/26/1993
Decision Date 06/16/1994
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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