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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 K992621
Device Name ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES
Applicant
Advanced Diagnostics & Interventions
216 Via Linda Vista
Redondo Beach,  CA  90277
Applicant Contact ANTONY FENDER
Correspondent
Advanced Diagnostics & Interventions
216 Via Linda Vista
Redondo Beach,  CA  90277
Correspondent Contact ANTONY FENDER
Regulation Number888.1100
Classification Product Code
HRX  
Date Received08/05/1999
Decision Date 11/08/1999
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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