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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, porous uncemented
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
Applicant Contact DOUGLAS G NOILES
Correspondent
JOINT MEDICAL PRODUCTS CORP.
860 CANAL ST.
STAMFORD,  CT  06902
Correspondent Contact DOUGLAS G NOILES
Regulation Number888.3358
Classification Product Code
LPH  
Date Received04/10/1985
Decision Date 06/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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