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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 K890601
Device Name STUART TITANIUM SURGICAL MESH
Applicant
Stuart
One Stuart Plz.
Donohue/Luxor Rd.S
Greensburg,  PA  15601
Applicant Contact ABRAHAM GLASSER
Correspondent
Stuart
One Stuart Plz.
Donohue/Luxor Rd.S
Greensburg,  PA  15601
Correspondent Contact ABRAHAM GLASSER
Regulation Number878.3300
Classification Product Code
EZX  
Date Received02/06/1989
Decision Date 03/16/1989
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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