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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K894929
Device Name STAPLE FIXATION SYSTEM
Applicant
Concept, Inc.
11311 Concept Blvd.
Largo,  FL  34643
Applicant Contact MARTHA MILLER
Correspondent
Concept, Inc.
11311 Concept Blvd.
Largo,  FL  34643
Correspondent Contact MARTHA MILLER
Regulation Number888.3030
Classification Product Code
JDR  
Date Received08/02/1989
Decision Date 08/30/1989
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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