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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Needle, Aspiration And Injection, Reusable
510(k) Number K903747
Device Name ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U
Applicant
Downs Surgical , Ltd.
Pkwy. Close,Pkwy.
Industrial Estate
Sheffield S9 4wj,  GB
Applicant Contact A. J NEWSON
Correspondent
Downs Surgical , Ltd.
Pkwy. Close,Pkwy.
Industrial Estate
Sheffield S9 4wj,  GB
Correspondent Contact A. J NEWSON
Regulation Number878.4800
Classification Product Code
GDM  
Date Received08/16/1990
Decision Date 10/31/1990
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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