FDA 510(k) Application Details - K955386

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

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510(K) Number K955386
Device Name Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Applicant U.S. MEDICAL PRODUCTS, INC.
12201 TECHNOLOGY BLVD., #100
AUSTIN, TX 78727 US
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Contact WILLIAM N THOMPSON
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Regulation Number 888.3353

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Classification Product Code LZO
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Date Received 11/22/1995
Decision Date 02/20/1996
Decision SN - Substantially Equivalent for Some Indications
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status
Type Traditional
Reviewed By Third Party N
Expedited Review



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