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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 K973590
Device Name HEMORRELIEF DEVICE
Applicant
A.Stein - Regulatory Affairs Consulting
P.O.B. 454
Ginot Shomron 44853,  IL 44853
Applicant Contact AHAVA STEIN
Correspondent
A.Stein - Regulatory Affairs Consulting
P.O.B. 454
Ginot Shomron 44853,  IL 44853
Correspondent Contact AHAVA STEIN
Classification Product Code
LKX  
Date Received09/22/1997
Decision Date 02/05/1998
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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