FDA 510(k) Application Details - K990003

Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

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510(K) Number K990003
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Applicant OSTEOIMPLANT TECHNOLOGY, INC.
11201 PEPPER RD.
HUNT VALLEY, MD 21031-1201 US
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Contact SAM SON
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Regulation Number 888.3358

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Classification Product Code LPH
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Date Received 01/04/1999
Decision Date 02/24/1999
Decision SESE - SUBST EQUIV
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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