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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 K852679
Device Name MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE
Applicant
J. & Jp., Inc.
12555 Biscayne Blvd.
Suite 970
North Miami Beach,  FL  33181
Applicant Contact JERZY POHLER
Correspondent
J. & Jp., Inc.
12555 Biscayne Blvd.
Suite 970
North Miami Beach,  FL  33181
Correspondent Contact JERZY POHLER
Classification Product Code
LKX  
Date Received06/25/1985
Decision Date 08/09/1985
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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