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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 November 7, 1991. The device falls under product code LKX (Device, Thermal, Hemorrhoids), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 7, 1991
Date Received
November 23, 1990
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

Other clearances for product code LKX

  • K172358 — Instalief (January 10, 2018)
  • K113660 — COLD PACK, PLASTIC APPLICATOR (MEDICAL GRADE)-NON-CHEMICAL (May 3, 2012)
  • K072414 — CRYOSTAT (April 7, 2008)
  • K042564 — HEMOR-RITE CRYOTHERAPHY (September 30, 2005)
  • K012746 — ICE BATON (November 14, 2001)
  • K981428 — ANU ICE (July 7, 1998)
  • K973590 — HEMORRELIEF DEVICE (February 5, 1998)
  • K944874 — ZEROID HEMORRHOIDAL DEVICE (August 7, 1995)
  • K921189 — THERMA-H (August 31, 1992)
  • K883984 — HEMORX COLD PACK (December 22, 1988)

FDA data resources