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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name media and components, synthetic cell and tissue culture
510(k) Number K850886
Device Name COMPRESSION HIP SCREW SYSTEM
Applicant
PFIZER, INC.
235 E 42ND ST.
NY,  NY  10017
Applicant Contact RONALD DUCHENE
Correspondent
PFIZER, INC.
235 E 42ND ST.
NY,  NY  10017
Correspondent Contact RONALD DUCHENE
Regulation Number864.2220
Classification Product Code
KIT  
Date Received03/04/1985
Decision Date 04/19/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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