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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 K843690
Device Name ILLINOIS STERNUM/ILIAC ASPIRATION NEEDLE
Applicant
Popper & Sons, Inc.
300 Denton Ave.
New Hyde Park,  NY  11040
Applicant Contact ROBERT A POPPER
Correspondent
Popper & Sons, Inc.
300 Denton Ave.
New Hyde Park,  NY  11040
Correspondent Contact ROBERT A POPPER
Regulation Number878.4800
Classification Product Code
GDM  
Date Received09/19/1984
Decision Date 10/25/1984
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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