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FDA 510(k) Application Details - K041583
Device Classification Name
Prosthesis, Hip, Cement Restrictor
More FDA Info for this Device
510(K) Number
K041583
Device Name
Prosthesis, Hip, Cement Restrictor
Applicant
INNOVASIS, INC.
997 EAST 3900 SOUTH
SUITE 103
SALT LAKE CITY, UT 84124 US
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Contact
BRENT A FELIX
Other 510(k) Applications for this Contact
Regulation Number
878.3300
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Classification Product Code
JDK
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More FDA Info for this Product Code
Date Received
06/11/2004
Decision Date
07/22/2004
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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