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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 Uncemented Acetabular Component)
510(k) Number K852351
Device Name KIRSCHNER SELF-TAPPING ACETABULAR CUP
Applicant
Kirschner Medical Corp.
9690 Deereco Rd.D
Timonium,  MD  21093
Applicant Contact SAM SON
Correspondent
Kirschner Medical Corp.
9690 Deereco Rd.D
Timonium,  MD  21093
Correspondent Contact SAM SON
Regulation Number888.3330
Classification Product Code
KWA  
Date Received05/31/1985
Decision Date 08/09/1985
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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