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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Femoral, Resurfacing
510(k) Number K761324
Device Name RESURFACE PROSTHESES FOR HIP JOINT
Applicant
Holco Instrument Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Holco Instrument Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3400
Classification Product Code
KXA  
Date Received12/27/1976
Decision Date 01/05/1977
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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