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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 K940643
Device Name OSMED EPI-GUIDE
Applicant
THM BIOMEDICAL, INC.
325 LAKE AVE. S. STE. #608
DULUTH,  MN  55802
Applicant Contact DAVID LANGLEY
Correspondent
THM BIOMEDICAL, INC.
325 LAKE AVE. S. STE. #608
DULUTH,  MN  55802
Correspondent Contact DAVID LANGLEY
Regulation Number872.3930
Classification Product Code
LYC  
Date Received02/14/1994
Decision Date 10/15/1996
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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