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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bone grafting material, synthetic
510(k) Number K010775
Device Name BIOCELLECT
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
LYC  
Date Received03/14/2001
Decision Date 06/12/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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