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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mesh, Surgical
510(k) Number K922308
Device Name TILGHMAN TITANIUM MESH SKELETAL ORBIT LINER
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 Number878.3300
Classification Product Code
FTM  
Date Received05/15/1992
Decision Date 01/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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