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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 K925226
Device Name SIGHT-PLUS ARTHROSCOPE
Applicant
American Medical Concepts, Inc.
1544 Sawdust Rd., Suite 502
The Woodlands,  TX  77380
Applicant Contact RICHARD L BENSON
Correspondent
American Medical Concepts, Inc.
1544 Sawdust Rd., Suite 502
The Woodlands,  TX  77380
Correspondent Contact RICHARD L BENSON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received10/16/1992
Decision Date 07/28/1993
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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