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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 K944874
Device Name ZEROID HEMORRHOIDAL DEVICE
Applicant
Medical Appliance Research Corp.
3780 NE 167th St.
North Miami Beach,  FL  33160
Applicant Contact MURRAY CERAMI
Correspondent
Medical Appliance Research Corp.
3780 NE 167th St.
North Miami Beach,  FL  33160
Correspondent Contact MURRAY CERAMI
Classification Product Code
LKX  
Date Received10/03/1994
Decision Date 08/07/1995
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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