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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 K921189
Device Name THERMA-H
Applicant
Zewa AG
10438 NW 31st Ter.
Miami,  FL  33172
Applicant Contact BURK A BRANDT
Correspondent
Zewa AG
10438 NW 31st Ter.
Miami,  FL  33172
Correspondent Contact BURK A BRANDT
Classification Product Code
LKX  
Date Received03/03/1992
Decision Date 08/31/1992
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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