FDA 510(k) Applications for Medical Device Product Code "LKX"
(Device, Thermal, Hemorrhoids)

FDA 510(k) Number Applicant Device Name Decision Date
K973590 A. STEIN - REGULATORY AFFAIRS CONSULTING HEMORRELIEF DEVICE 02/05/1998
K012746 BEHIVE LTD ICE BATON 11/14/2001
K981428 CRYOPTHERAPY PAIN RELIEF PRODUCTS, INC. ANU ICE 07/07/1998
K113660 CRYOTHERAPY PRODUCTS INC. COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL 05/03/2012
K042564 FAMA HOLDINGS INTERNATIONAL CORP HEMOR-RITE CRYOTHERAPHY 09/30/2005
K072414 LIL DRUG STORE PRODUCTS, INC. CRYOSTAT 04/07/2008
K172358 Privi Medical Pte Ltd Instalief 01/10/2018


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