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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 K941486
Device Name INTEGRITY TOTAL HIP SYSTEM, NON-POROUS
Applicant
Kirschner Medical Corp.
20-01 Pollitt Dr.
Fair Lawn,  NJ  07410
Applicant Contact JACQUELINE HUGHES
Correspondent
Kirschner Medical Corp.
20-01 Pollitt Dr.
Fair Lawn,  NJ  07410
Correspondent Contact JACQUELINE HUGHES
Regulation Number888.3350
Classification Product Code
JDI  
Subsequent Product Code
LZO  
Date Received03/28/1994
Decision Date 09/20/1994
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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