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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, Intraosseous
510(k) Number K982951
Device Name IMTEC BIOPIN
Applicant
Imtec Corp.
2401 N Commerce
Ardmore,  OK  73401
Applicant Contact M.K. PATTERSON
Correspondent
Imtec Corp.
2401 N Commerce
Ardmore,  OK  73401
Correspondent Contact M.K. PATTERSON
Regulation Number872.4880
Classification Product Code
DZL  
Date Received08/24/1998
Decision Date 06/21/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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