FDA.reportPublic FDA data

510(k) K012746

Device
ICE BATON
Applicant
Behive, Ltd.
510(k) number
K012746
Product code
LKX
Decision
Substantially Equivalent (SESE)
Decision date
2001-11-14
Date received
2001-08-16
Classification name
Device, Thermal, Hemorrhoids
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
MARY MCNAMARA-CULLINANE
Address
49 Plain St. North Attleboro MA US 02760 02760

Source Documents#

510(k) summary PDF

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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