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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(k) Number K896851
Device Name PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC
Applicant
Lima Intl. Corp.
392 Wampanoag Trl.
E Providence,  RI  02915
Applicant Contact POLLONIO-LISTER
Correspondent
Lima Intl. Corp.
392 Wampanoag Trl.
E Providence,  RI  02915
Correspondent Contact POLLONIO-LISTER
Regulation Number888.3350
Classification Product Code
JDI  
Date Received12/05/1989
Decision Date 01/01/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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