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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Elbow, Hemi-, Radial, Polymer
510(k) Number K885146
Device Name CL UNIVERSAL HIP DEVICE
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 Number888.3170
Classification Product Code
KWI  
Date Received12/15/1988
Decision Date 04/24/1989
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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