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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Probe
510(k) Number K912843
Device Name FLEXMEDICS RETRACT ORTH PROBE, PETTINE BONE PROBE
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 Number888.4540
Classification Product Code
HXB  
Date Received06/26/1991
Decision Date 09/24/1991
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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