FDA 510(k) Application Details - K001942

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

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510(K) Number K001942
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Applicant PLUS ORTHOPEDICS
3550 GENERAL ATOMICS CT.
BLDG. 15-100
SAN DIEGO, CA 92121-1122 US
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Contact HARTMUT LOCH
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Regulation Number 888.3360

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Classification Product Code LWJ
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Date Received 06/26/2000
Decision Date 07/25/2000
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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