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510(k) K905276

THERMA-H by Kure Swiss Medical AG Corp. — Product Code LKX

K905276 is an FDA 510(k) premarket notification submitted by Kure Swiss Medical AG Corp. for the device "THERMA-H". The FDA issued a decision of Substantially Equivalent on Nov 7, 1991. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 7, 1991
Date Received
Nov 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Thermal, Hemorrhoids
Device Class
Class U
Review Panel
GU
Submission Type
510(k)

Other clearances for product code LKX

  • K172358 — Instalief (Jan 10, 2018)
  • K113660 — COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL (May 3, 2012)
  • K072414 — CRYOSTAT (Apr 7, 2008)
  • K042564 — HEMOR-RITE CRYOTHERAPHY (Sep 30, 2005)
  • K012746 — ICE BATON (Nov 14, 2001)
  • K981428 — ANU ICE (Jul 7, 1998)
  • K973590 — HEMORRELIEF DEVICE (Feb 5, 1998)
  • K944874 — ZEROID HEMORRHOIDAL DEVICE (Aug 7, 1995)
  • K921189 — THERMA-H (Aug 31, 1992)
  • K883984 — HEMORX COLD PACK (Dec 22, 1988)

FDA data resources