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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Implantable
510(k) Number K983318
Device Name FIXATION SYSTEM
Applicant
General Surgical Innovations
10460 Bubb Rd.
Cupertino,  CA  95014
Applicant Contact FEROLYN T POWELL
Correspondent
General Surgical Innovations
10460 Bubb Rd.
Cupertino,  CA  95014
Correspondent Contact FEROLYN T POWELL
Regulation Number878.4750
Classification Product Code
GDW  
Date Received09/21/1998
Decision Date 03/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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