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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 K042564
Device Name HEMOR-RITE CRYOTHERAPHY
Applicant
Fama Holdings International Corp
6202 NW 88th Ave.
Parkland,  FL  33067
Applicant Contact FRANK MELENDEZ
Correspondent
Fama Holdings International Corp
6202 NW 88th Ave.
Parkland,  FL  33067
Correspondent Contact FRANK MELENDEZ
Classification Product Code
LKX  
Date Received09/21/2004
Decision Date 09/30/2005
Decision Substantially Equivalent (SESE)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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