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510(k) K834127

INSTRUMENT TIP PROTECTION COVERS by Devon Industries, Inc. — Product Code LXZ

K834127 is an FDA 510(k) premarket notification submitted by Devon Industries, Inc. for the device "INSTRUMENT TIP PROTECTION COVERS". The FDA issued a decision of Substantially Equivalent on February 17, 1984. The device falls under product code LXZ (Guard, Instrument), a Class I device regulated under 21 CFR 878.4800. Devon Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 1984
Date Received
November 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Guard, Instrument
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances by Devon Industries, Inc.

  • K961993 — BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT) (July 3, 1996)
  • K954015 — ABG POINT LOK NEEDLE PROTECTION DEVICE (November 20, 1995)
  • K946289 — DEVONS POINT LOK NEEDLE PROTECTION DEVICE (July 10, 1995)
  • K944114 — PHLEBOTOMY UNIT SHARPS A GATOR (December 2, 1994)
  • K945197 — THE SHARPS COLLECTION AND DISPOSAL SYSTEM (December 2, 1994)
  • K943892 — POINT OF USE SHARPS A GATOR (December 2, 1994)
  • K945485 — ABG NEEDLE PROTECTION (November 29, 1994)
  • K932998 — EASY-ON (August 18, 1993)
  • K912824 — DEVON SPONGE COUNTER BAGS (August 26, 1991)
  • K894170 — DEVON DISPOSABLE HEAD POSITIONER COVER (September 7, 1989)

Other clearances for product code LXZ

  • K955463 — GRIP-A-BOOTS (January 23, 1996)

FDA data resources