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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dispenser, Cement
510(k) Number K943906
Device Name P.F.C. CEMENT PRESSURIZING SYSTEM
Applicant
Johnson & Johnson Professionals, Inc.
Orthopedic Division
325 Paramount Dr.
Raynham,  MA  02767
Applicant Contact JOHN D FERROS
Correspondent
Johnson & Johnson Professionals, Inc.
Orthopedic Division
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact JOHN D FERROS
Regulation Number888.4200
Classification Product Code
KIH  
Date Received08/11/1994
Decision Date 12/21/1994
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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