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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, Cemented
510(k) Number K840357
Device Name SSA HIP PROSTHESIS
Applicant
Dow Corning Corp. Healthcare Industries Materials
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Dow Corning Corp. Healthcare Industries Materials
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number888.3350
Classification Product Code
JDI  
Date Received01/26/1984
Decision Date 02/17/1984
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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