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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 uncemented acetabular component)
510(K) Number K851421
Device Name S-ROM ACETABULAR CUP(PART OF S-ROM 135TM TOTAL HIP
Applicant
JOINT MEDICAL PRODUCTS CORP.
860 canal st.
stamford,  CT  06902
Contact douglas g noiles
Regulation Number888.3330
Classification Product Code
KWA  
Date Received04/10/1985
Decision Date 06/04/1985
Decision substantially equivalent (SE)
Classification Advisory Committee Orthopedic
Review Advisory Committee Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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