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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
510(k) Number K850403
Device Name MEC DISTAL FEMORAL BOLT
Applicant
Pfizer, Inc.
235 E. 42nd St.
Ny,  NY  10017
Applicant Contact BARBARA G RAMSEYER
Correspondent
Pfizer, Inc.
235 E. 42nd St.
Ny,  NY  10017
Correspondent Contact BARBARA G RAMSEYER
Regulation Number888.3030
Classification Product Code
KTT  
Date Received02/01/1985
Decision Date 07/15/1985
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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