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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K021586
Device Name SECURE RELINE/PICKUP MATERIAL
Applicant
IMTEC CORP.
2401 NORTH COMMERCE
ARDMORE,  OK  73401
Applicant Contact BRAD VANCE
Correspondent
IMTEC CORP.
2401 NORTH COMMERCE
ARDMORE,  OK  73401
Correspondent Contact BRAD VANCE
Regulation Number872.3760
Classification Product Code
EBI  
Date Received05/14/2002
Decision Date 06/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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