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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biopsy Needle
510(k) Number K911397
Device Name HYPODERMIC NEEDLES, SINGLE LUMEN
Applicant
POPPER & SONS, INC.
300 DENTON AVE.
NEW HYDE PARK,  NY  11040
Applicant Contact JOSEPH A POPPER
Correspondent
POPPER & SONS, INC.
300 DENTON AVE.
NEW HYDE PARK,  NY  11040
Correspondent Contact JOSEPH A POPPER
Regulation Number876.1075
Classification Product Code
FCG  
Date Received03/29/1991
Decision Date 05/20/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
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