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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Driver, Prosthesis
510(k) Number K915776
Device Name KNEE PROSTHESIS DRIVER
Applicant
Kim-Med, Inc.
1407 Kansas Ave.
Kansas City,  MO  64127
Applicant Contact WILLIAM W BOHN
Correspondent
Kim-Med, Inc.
1407 Kansas Ave.
Kansas City,  MO  64127
Correspondent Contact WILLIAM W BOHN
Regulation Number888.4540
Classification Product Code
HWR  
Date Received12/24/1991
Decision Date 06/11/1992
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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