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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 K960020
Device Name SOLO BAND LIGATOR
Applicant
Surcraft, LLC
Plz. One
12368 Warwick Blvd.
Newport News,  VA  23606
Applicant Contact JACOBUS BUDDING
Correspondent
Surcraft, LLC
Plz. One
12368 Warwick Blvd.
Newport News,  VA  23606
Correspondent Contact JACOBUS BUDDING
Regulation Number876.4400
Classification Product Code
FHN  
Date Received01/02/1996
Decision Date 04/01/1996
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
Predetermined Change
Control Plan Authorized		 No
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