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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Forceps
510(k) Number K051281
Device Name THE NEEDLE CATCHER
Applicant
E.D.MEDICAL LTD.
32 CRANMORE AVENUE LISBURN RD
BELFAST,  GB BT96JH
Applicant Contact BRIAN MCNICHOLL
Correspondent
E.D.MEDICAL LTD.
32 CRANMORE AVENUE LISBURN RD
BELFAST,  GB BT96JH
Correspondent Contact BRIAN MCNICHOLL
Regulation Number878.4800
Classification Product Code
HTD  
Date Received05/17/2005
Decision Date 09/08/2005
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
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