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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 K923802
Device Name TIMESH TITANIUM MINI-SOFTPLATE/SCREW
Applicant
Ti-Mesh, Inc.
76 Spectrum Rd.
Las Vegas,  NV  89101
Applicant Contact MARY R MORGAN
Correspondent
Ti-Mesh, Inc.
76 Spectrum Rd.
Las Vegas,  NV  89101
Correspondent Contact MARY R MORGAN
Regulation Number872.4760
Classification Product Code
JEY  
Date Received07/29/1992
Decision Date 10/26/1992
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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