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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 K870523
Device Name HAWKINS BREAST LOCALIZATION NEEDLE
Applicant
N-S Medical Products
4435 SW 35th Terrace
Suite 360
Gainesville,  FL  32608
Applicant Contact KEITH L STAHL
Correspondent
N-S Medical Products
4435 SW 35th Terrace
Suite 360
Gainesville,  FL  32608
Correspondent Contact KEITH L STAHL
Regulation Number878.4800
Classification Product Code
GDM  
Date Received02/06/1987
Decision Date 03/09/1987
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
Recalls CDRH Recalls
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