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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 K953268
Device Name DUAL TAPER WEDGE PRESSED FIT FEMORAL COMPONENT
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  
Subsequent Product Code
JDZ  
Date Received07/13/1995
Decision Date 01/17/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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