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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 K934412
Device Name COATED ZT PROXIMAL SLEEVE
Applicant
Joint Medical Products Corp.
860 Canal St.
Stamford,  CT  06902
Applicant Contact KEVIN J CROSSEN
Correspondent
Joint Medical Products Corp.
860 Canal St.
Stamford,  CT  06902
Correspondent Contact KEVIN J CROSSEN
Regulation Number888.3358
Classification Product Code
LPH  
Date Received09/10/1993
Decision Date 06/03/1994
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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