MAMMARY ASPIRATION SPECIMEN CYTOLOGY TEST


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

Correspodent Contact peter c aprile
Regulation Number 876.1075
Classification Product Code
KNW  
Date Received 02/11/2003
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