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FDA 510(k) Application Details - K001942
Device Classification Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
More FDA Info for this Device
510(K) Number
K001942
Device Name
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
Applicant
PLUS ORTHOPEDICS
3550 GENERAL ATOMICS CT.
BLDG. 15-100
SAN DIEGO, CA 92121-1122 US
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Contact
HARTMUT LOCH
Other 510(k) Applications for this Contact
Regulation Number
888.3360
More FDA Info for this Regulation Number
Classification Product Code
LWJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/26/2000
Decision Date
07/25/2000
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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