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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 K992474
Device Name ARTHROSCOPE / MEDIFIX INC.
Applicant
Medifix, Inc.
8727 Narragansett
Morton Grove,  IL  60053
Applicant Contact GEORGE ALBUSECU
Correspondent
Medifix, Inc.
8727 Narragansett
Morton Grove,  IL  60053
Correspondent Contact GEORGE ALBUSECU
Regulation Number888.1100
Classification Product Code
HRX  
Date Received07/26/1999
Decision Date 09/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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