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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K912957
Device Name CONCEPT MICROMILL
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 Number888.1100
Classification Product Code
HRX  
Date Received07/08/1991
Decision Date 10/04/1991
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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