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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, Metal
510(k) Number K896369
Device Name TITANIUM MESH MAXILLOFACIAL IMPLANT SYSTEM
Applicant
Techmedica, Inc.
1380 Flynn Rd.
Camarillo,  CA  93010
Applicant Contact GARY KELSEY
Correspondent
Techmedica, Inc.
1380 Flynn Rd.
Camarillo,  CA  93010
Correspondent Contact GARY KELSEY
Regulation Number878.3300
Classification Product Code
EZX  
Date Received11/06/1989
Decision Date 11/24/1989
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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