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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 K902621
Device Name SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT
Applicant
LIMA INTL. CORP.
392 WAMPANOAG TRAIL
E PROVIDENCE,  RI  02915
Applicant Contact L POLLONIO-LISTER
Correspondent
LIMA INTL. CORP.
392 WAMPANOAG TRAIL
E PROVIDENCE,  RI  02915
Correspondent Contact L POLLONIO-LISTER
Regulation Number888.3350
Classification Product Code
JDI  
Date Received06/14/1990
Decision Date 09/11/1990
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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