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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 K910674
Device Name FLEXMEDICS MALLEABLE CANNULA
Applicant
Flexmedics
620 Ford Ctr., 420 N. Fifth
St.
Minneapolis,  MN  55401
Applicant Contact TIMOTHY LEY
Correspondent
Flexmedics
620 Ford Ctr., 420 N. Fifth
St.
Minneapolis,  MN  55401
Correspondent Contact TIMOTHY LEY
Regulation Number888.1100
Classification Product Code
HRX  
Date Received02/15/1991
Decision Date 04/12/1991
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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