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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
Applicant
NASTECH PHARMACEUTICAL COMPANY, INC.
45 ADAMS AVE.
HAUPPAUGE,  NY  11788 -3605
Applicant Contact PETER C APRILE
Correspondent
NASTECH PHARMACEUTICAL COMPANY, INC.
45 ADAMS AVE.
HAUPPAUGE,  NY  11788 -3605
Correspondent 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 Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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