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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoscopic Cytology Brush
510(k) Number K913248
Device Name CYTOLOGY BRUSH
Applicant
Annex Medical, Inc.
7887 Fuller Rd. #109
Eden Prairie,  MN  55344
Applicant Contact STUART J LIND
Correspondent
Annex Medical, Inc.
7887 Fuller Rd. #109
Eden Prairie,  MN  55344
Correspondent Contact STUART J LIND
Regulation Number876.1500
Classification Product Code
FDX  
Date Received07/22/1991
Decision Date 09/30/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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