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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reamer
510(k) Number K885100
Device Name MCCONNELL REAMER GUIDE
Applicant
Mcconnell Orthopedic
Treee Lincoln Centre
5430 Lbj Fwy. Suite 1540
Dallas,  TX  75240
Applicant Contact DENNIS T GRIGGS
Correspondent
Mcconnell Orthopedic
Treee Lincoln Centre
5430 Lbj Fwy. Suite 1540
Dallas,  TX  75240
Correspondent Contact DENNIS T GRIGGS
Regulation Number888.4540
Classification Product Code
HTO  
Date Received12/12/1988
Decision Date 01/13/1989
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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