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510(k) K042555

SURGICHIP TAG SURGICAL MARKER by Surgichip, Inc. — Product Code FZZ

K042555 is an FDA 510(k) premarket notification submitted by Surgichip, Inc. for the device "SURGICHIP TAG SURGICAL MARKER". The FDA issued a decision of Substantially Equivalent on November 9, 2004. The device falls under product code FZZ (Marker, Skin), a Class I device regulated under 21 CFR 878.4660.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2004
Date Received
September 20, 2004
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 for product code FZZ

  • 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)
  • K844865 — SECURLINE SURGICAL SKIN MARKER 1000 (January 14, 1985)

FDA data resources