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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 K894303
Device Name MEDSCOPE 4MM ARTHROSCOPE
Applicant
Medscope Corp.
495 Lindberg Ln.
Northbrook,  IL  60062
Applicant Contact JOACHIM SPIESS
Correspondent
Medscope Corp.
495 Lindberg Ln.
Northbrook,  IL  60062
Correspondent Contact JOACHIM SPIESS
Regulation Number888.1100
Classification Product Code
HRX  
Date Received06/23/1989
Decision Date 07/25/1989
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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