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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 K091398
Device Name ARTHROSCOPE
Applicant
Orthopedic Sciences, Inc.
3020 Old Ranch Pkwy.
Suite 325
Seal Beach,  CA  90740
Applicant Contact JAMES K BRANNON
Correspondent
Orthopedic Sciences, Inc.
3020 Old Ranch Pkwy.
Suite 325
Seal Beach,  CA  90740
Correspondent Contact JAMES K BRANNON
Regulation Number888.1100
Classification Product Code
HRX  
Date Received05/12/2009
Decision Date 08/26/2009
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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