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510(k) K983045

AMIELLE by Owen Mumford USA, Inc. — Product Code KXP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1998
Date Received
September 1, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stent, Vaginal
Device Class
Class II
Regulation Number
884.3900
Review Panel
OB
Submission Type

Other clearances by Owen Mumford USA, Inc.

  • K013362 — AUTOJECT 2 (November 13, 2001)
  • K993385 — AUTOJET 2 (NON-FIXED NEEDLE TYPE) (November 10, 1999)
  • K983994 — UNIFINE (January 8, 1999)
  • K983974 — OWEN MUMFORD 3ML AUTOPEN (December 21, 1998)
  • K982275 — RAPPORT V.T.D. (December 4, 1998)
  • K973899 — UNIFINE PENTIPS (December 4, 1997)
  • K971443 — RAPPORT V.T.D. (September 26, 1997)
  • K953735 — AUTOJECT MINI (November 8, 1995)
  • K945660 — AUTOJECT 2 (August 11, 1995)

Other clearances for product code KXP

  • K202542 — Allura Vaginal Stent (September 30, 2020)
  • K974479 — SILIMED VAGINAL STENT (August 5, 1998)
  • K920633 — PESSARY FLEXIBLE SILICONE NICHOLS (November 8, 1995)