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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, Uncemented
510(k) Number K870088
Device Name S-ROM SUPERCUP ACETABULAR CUP
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 Number888.3360
Classification Product Code
LWJ  
Date Received01/09/1987
Decision Date 04/22/1988
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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