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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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