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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, biopsy
510(k) Number K030443
Device Name MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST
Original Applicant
NASTECH PHARMACEUTICAL COMPANY, INC.
45 adams ave.
hauppauge,  NY  11788 -3605
Original Contact peter c aprile
Regulation Number876.1075
Classification Product Code
KNW  
Date Received02/11/2003
Decision Date 05/09/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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