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510(k) K862490

ANU-RX by J. & Jp., Inc. — Product Code LKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1986
Date Received
July 1, 1986
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 by J. & Jp., Inc.

  • K852679 — MULTIPLE(HEMORX) IF APPROVED BY TRADEMARK OFFICE (August 9, 1985)

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)
  • K905276 — THERMA-H (November 7, 1991)