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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 K002796
Device Name MODIFICATION TO PROVIDENT HIP SYSTEM
Applicant
STELKAST COMPANY
800 VINIAL ST. #210
PITTSBURGH,  PA  15212
Applicant Contact DONALD A STEVENS
Correspondent
STELKAST COMPANY
800 VINIAL ST. #210
PITTSBURGH,  PA  15212
Correspondent Contact DONALD A STEVENS
Regulation Number888.3360
Classification Product Code
LWJ  
Date Received09/07/2000
Decision Date 09/28/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
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