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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 K900138
Device Name MOTECH TITANIUM SURGICAL MESH
Applicant
Biedermann Motech GmbH
18159 Village Mart Dr.
Suite 243
Olney,  MD  20832
Applicant Contact ARTHUR B MCINTYRE
Correspondent
Biedermann Motech GmbH
18159 Village Mart Dr.
Suite 243
Olney,  MD  20832
Correspondent Contact ARTHUR B MCINTYRE
Regulation Number878.3300
Classification Product Code
EZX  
Date Received01/11/1990
Decision Date 03/20/1990
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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