510(k) K012746

ICE BATON by Behive, Ltd. — Product Code LKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2001
Date Received
August 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Thermal, Hemorrhoids
Device Class
Class U
Regulation Number
Review Panel
GU
Submission Type