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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ligator, hemorrhoidal
510(k) Number K091519
Device Name HAEMOBAND MULTI-LIGATOR
Applicant
HAEMOBAND SURGICAL LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
HAEMOBAND SURGICAL LTD.
24301 WOODSAGE DRIVE
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Regulation Number876.4400
Classification Product Code
FHN  
Date Received05/22/2009
Decision Date 07/28/2009
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
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