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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clip, Implantable
510(k) Number K032238
Device Name TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER
Applicant
Neurosel (Medical) Limited
Greenways
Abbotts Ann
Andover, Hampshire,  GB SP11 7BH
Applicant Contact PETER GIBSON
Correspondent
Neurosel (Medical) Limited
Greenways
Abbotts Ann
Andover, Hampshire,  GB SP11 7BH
Correspondent Contact PETER GIBSON
Regulation Number878.4300
Classification Product Code
FZP  
Date Received07/21/2003
Decision Date 09/09/2003
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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