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510(k) K821063

SKIN MARKERS by Devon Industries, Inc. — Product Code FZZ

K821063 is an FDA 510(k) premarket notification submitted by Devon Industries, Inc. for the device "SKIN MARKERS". The FDA issued a decision of Substantially Equivalent on June 25, 1982. The device falls under product code FZZ (Marker, Skin), a Class I device regulated under 21 CFR 878.4660. Devon Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 1982
Date Received
March 7, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Marker, Skin
Device Class
Class I
Regulation Number
878.4660
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)
  • K943892 — POINT OF USE SHARPS A GATOR (December 2, 1994)
  • K945197 — THE SHARPS COLLECTION AND DISPOSAL SYSTEM (December 2, 1994)
  • K944114 — PHLEBOTOMY UNIT 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 FZZ

  • K042555 — SURGICHIP TAG SURGICAL MARKER (November 9, 2004)
  • K915066 — DISPOSABLE SKIN MARKER (May 14, 1992)
  • K914759 — BLOOM TRANSPARENT STENCIL (April 21, 1992)
  • K912730 — ROCKET SURGICAL SKIN MARKING PEN (November 7, 1991)
  • K905143 — SKIN MARKER (February 6, 1991)
  • K904559 — QUALTEX SKIN MARKER (December 13, 1990)
  • K896792 — SURGICAL SKIN MARKER (December 27, 1989)
  • K864371 — SURGICAL SKIN MARKER (November 17, 1986)
  • K863280 — DERMAMARKER (September 9, 1986)
  • K861772 — LASER SKIN MARKER AND MASK WHITE LOTION (May 21, 1986)

FDA data resources