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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K912640
Device Name CONCEPT ENDOSTEAL FIXATION DEVICE
Applicant
Concept, Inc.
11311 Concept Blvd.
Largo,  FL  34643
Applicant Contact PENNY C RASMUSSEN
Correspondent
Concept, Inc.
11311 Concept Blvd.
Largo,  FL  34643
Correspondent Contact PENNY C RASMUSSEN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received06/14/1991
Decision Date 05/01/1992
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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