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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 K950306
Device Name IMTEC BIOBARRIER
Applicant
IMTEC CORP.
2007 N. COMMERCE
P.O. BOX 1562
ARDMORE,  OK  73402
Applicant Contact E. S GILLESPIE
Correspondent
IMTEC CORP.
2007 N. COMMERCE
P.O. BOX 1562
ARDMORE,  OK  73402
Correspondent Contact E. S GILLESPIE
Regulation Number872.3930
Classification Product Code
LYC  
Date Received01/25/1995
Decision Date 02/06/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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