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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Thermal, Hemorrhoids
510(k) Number K905276
Device Name THERMA-H
Applicant
Kure Swiss Medical AG Corp.
501 Brickell Key Dr.
Miami,  FL  33131
Applicant Contact EDGAR HOFFMAN
Correspondent
Kure Swiss Medical AG Corp.
501 Brickell Key Dr.
Miami,  FL  33131
Correspondent Contact EDGAR HOFFMAN
Classification Product Code
LKX  
Date Received11/23/1990
Decision Date 11/07/1991
Decision Substantially Equivalent (SESE)
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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