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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name plate, bone
510(k) Number K923419
Device Name TISMESH SYSTEM
Applicant
TI-MESH, INC.
76 SPECTRUM RD.
LAS VEGAS,  NV  89101
Applicant Contact MARY P MORGAN
Correspondent
TI-MESH, INC.
76 SPECTRUM RD.
LAS VEGAS,  NV  89101
Correspondent Contact MARY P MORGAN
Regulation Number872.4760
Classification Product Code
JEY  
Date Received07/13/1992
Decision Date 04/08/1993
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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