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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nail, Fixation, Bone
510(k) Number K800894
Device Name DUPUY CEMENT RESTRICTOR TRIALS & INSTR.
Applicant
DEPUY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DEPUY, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3030
Classification Product Code
JDS  
Date Received04/18/1980
Decision Date 05/02/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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