FDA 510(k) Application Details - K993569

Device Classification Name Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)

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510(K) Number K993569
Device Name Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Applicant SULZER MEDICA
9900 SPECTRUM DR.
AUSTIN, TX 78717 US
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Contact MITCHELL A DHORITY
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Regulation Number 888.3330

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Classification Product Code KWA
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Date Received 10/21/1999
Decision Date 12/01/1999
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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