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FDA 510(k) Application Details - K972760
Device Classification Name
Prosthesis, Hip, Acetabular Mesh
More FDA Info for this Device
510(K) Number
K972760
Device Name
Prosthesis, Hip, Acetabular Mesh
Applicant
LINK AMERICA, INC.
321 PALMER RD.
DENVILLE, NJ 07834 US
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Contact
DOUGLAS W STUART
Other 510(k) Applications for this Contact
Regulation Number
878.3300
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Classification Product Code
JDJ
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More FDA Info for this Product Code
Date Received
07/24/1997
Decision Date
10/22/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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