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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Bone
510(k) Number K862139
Device Name IMTECH FIXATION SYSTEMS
Applicant
Imtech, Inc.
4348 S. Pt. Blvd., #203
Jacksonville,  FL  32216
Applicant Contact THOMAS E HILDEBRAND
Correspondent
Imtech, Inc.
4348 S. Pt. Blvd., #203
Jacksonville,  FL  32216
Correspondent Contact THOMAS E HILDEBRAND
Regulation Number872.4760
Classification Product Code
JEY  
Date Received06/04/1986
Decision Date 07/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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