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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Cushion, Hemorrhoid
510(k) Number K864470
Device Name HEMOREST(TM)
Applicant
Health Aid Products
5881 NW 151st St.
Suite 101a
Miami Lakes,  FL  33014
Applicant Contact PAUL SALVER
Correspondent
Health Aid Products
5881 NW 151st St.
Suite 101a
Miami Lakes,  FL  33014
Correspondent Contact PAUL SALVER
Classification Product Code
LRL  
Date Received11/12/1986
Decision Date 06/23/1987
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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