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510(k) K973590

Device
HEMORRELIEF DEVICE
Applicant
A. STEIN - REGULATORY AFFAIRS CONSULTING
510(k) number
K973590
Product code
LKX  
Decision
Substantially Equivalent (SESE)
Decision date
1998-02-05
Date received
1997-09-22
Regulation
510(k) Premarket Notification
Classification name
Device, Thermal, Hemorrhoids
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Gastroenterology/Urology
Device class
U
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
AHAVA STEIN
Address
P.O.B. 454 Ginot Shomron 44853 IL 44853 44853

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LKX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K172358InstaliefPrivi Medical Pte, Ltd.2018-01-10
K113660COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICALCryotherapy Products, Inc.2012-05-03
K072414CRYOSTATLil Drug Store Products, Inc.2008-04-07
K042564HEMOR-RITE CRYOTHERAPHYFama Holdings International Corp2005-09-30
K012746ICE BATONBehive, Ltd.2001-11-14
K981428ANU ICECryoptherapy Pain Relief Products, Inc.1998-07-07
K944874ZEROID HEMORRHOIDAL DEVICEMedical Appliance Research Corp.1995-08-07
K921189THERMA-HZewa AG1992-08-31
K905276THERMA-HKure Swiss Medical AG Corp.1991-11-07
K883984HEMORX COLD PACKBio-Dyne, Inc.1988-12-22
K862490ANU-RXJ. & Jp., Inc.1986-08-18
K855150HPK-A DEVICE DFOR THE TREATMENT OF HEMORRHOIDSHpk International, Inc.1986-04-01
K854569HEMOR-ICETechnology 20001986-02-05
K852679MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICEJ. & Jp., Inc.1985-08-09
K822649DEVICE FOR THE TREATMENT OF HEMORRHOIDSDunmore Corp.1982-11-03

Legacy Summary#

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FDA Review#

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