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FDA 510(k) Application Details - K970194
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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510(K) Number
K970194
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Applicant
STELKAST COMPANY
800 VINIAL ST. #210
PITTSBURGH, PA 15212 US
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Contact
DONALD A STEVENS
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Regulation Number
888.3350
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Classification Product Code
JDI
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More FDA Info for this Product Code
Date Received
01/21/1997
Decision Date
04/14/1997
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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