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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K042030
Device Name HYPROCURE SUBTALAR IMPLANT SYSTEM
Applicant
Graham Medical Technologies, LLC
45700 Schoenherr Rd.
Shelby Township,  MI  48315
Applicant Contact MICHAEL GRAHAM
Correspondent
Graham Medical Technologies, LLC
45700 Schoenherr Rd.
Shelby Township,  MI  48315
Correspondent Contact MICHAEL GRAHAM
Regulation Number888.3040
Classification Product Code
HWC  
Date Received07/28/2004
Decision Date 09/16/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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