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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 K954121
Device Name CYTOLOGY BRUSH
Applicant
LIGHTHOUSE MEDICAL, INC.
100 BEAVER ST.
WALTHAM,  MA  02154
Applicant Contact JENNA ANDELMAN
Correspondent
LIGHTHOUSE MEDICAL, INC.
100 BEAVER ST.
WALTHAM,  MA  02154
Correspondent Contact JENNA ANDELMAN
Regulation Number876.1500
Classification Product Code
FDX  
Date Received09/01/1995
Decision Date 10/07/1995
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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