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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Snare, Flexible
510(k) Number K960230
Device Name SNARE
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 Number876.4300
Classification Product Code
FDI  
Date Received01/17/1996
Decision Date 07/31/1996
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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