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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, Disposable
510(k) Number K896606
Device Name JACKSON FINE NEEDLE ASPIRATION SYSTEM
Applicant
National-Standard Medical Products
4445-360 SW 35th Ter.
Gainesville,  FL  32608
Applicant Contact ROBINSON
Correspondent
National-Standard Medical Products
4445-360 SW 35th Ter.
Gainesville,  FL  32608
Correspondent Contact ROBINSON
Regulation Number878.4800
Classification Product Code
GAA  
Date Received11/21/1989
Decision Date 01/04/1990
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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