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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name barrier, synthetic, intraoral
510(k) Number K974752
Device Name IMTEC/BIOBARRIER MEMBRANE
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 Number872.3930
Classification Product Code
NPK  
Date Received12/19/1997
Decision Date 03/03/1998
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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