FDA 510(k) Application Details - K990309

Device Classification Name Prosthesis, Hip, Hemi-, Femoral, Metal

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510(K) Number K990309
Device Name Prosthesis, Hip, Hemi-, Femoral, Metal
Applicant PLUS ORTHOPEDICS
3550 GENERAL ATOMICS CT.
BLDG. 15-100
SAN DIEGO, CA 92121-1194 US
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Contact HARTMUT LOCH
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Regulation Number 888.3360

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Classification Product Code KWL
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Date Received 02/01/1999
Decision Date 03/15/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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