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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, Hemi-, Femoral, Metal
510(k) Number K842559
Device Name WHITESIDE ORTHOLOC TOTAL HIP FEMORAL
Applicant
Dow Corning Corp. Healthcare Industries Materials
P.O. Box 1767 Midland,  MI  48640
Applicant Contact CARMEN D QUINSEY
Correspondent
Dow Corning Corp. Healthcare Industries Materials
P.O. Box 1767 Midland,  MI  48640
Correspondent Contact CARMEN D QUINSEY
Regulation Number888.3360
Classification Product Code
KWL  
Date Received07/02/1984
Decision Date 12/20/1984
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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