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510(k) K043249

ATRION NEEDLEVISE LARGE-BORE SHARPS SECURING DEVICE by Atrion Medical Products, Inc. — Product Code FMI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 2005
Date Received
November 23, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type

Other clearances by Atrion Medical Products, Inc.

  • K060643 — QL LOCKING SYRINGE (July 12, 2006)
  • K041158 — ATRION EPIDURAL ANESTHESIA KIT WITH ATRION NEEDLEVISE SHARPS SECURING SYSTEM (June 16, 2004)
  • K032840 — ATRION MEDICAL QL INFLATION DEVICE (March 3, 2004)
  • K020333 — ATRION MEDICAL QL FLUID DISPENSING SYRINGE (April 25, 2002)
  • K973633 — ATRION MEDICAL PRODUCTS LACRIMAL INTUBATION SET (January 16, 1998)
  • K973872 — ATRION MEDICAL COATED LACRIMAL INTUBATION SET (January 8, 1998)
  • K972964 — ATRION MEDICAL BALLOON CATHETER INFLATION DEVICE (October 10, 1997)
  • K971100 — ATRION MEDICAL AUTOGENOUS TISSUE COLLECTOR (May 23, 1997)

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