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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 K970841
Device Name IMTEC/TITANIUM MESH
Applicant
IMTEC CORP.
2401 NORTH COMMERCE
ARDMORE,  OK  73401
Applicant Contact M.K. PATTERSON
Correspondent
IMTEC CORP.
2401 NORTH COMMERCE
ARDMORE,  OK  73401
Correspondent Contact M.K. PATTERSON
Regulation Number872.4760
Classification Product Code
JEY  
Date Received03/07/1997
Decision Date 04/30/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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