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510(k) K863280

DERMAMARKER by Dermacare Products, Inc. — Product Code FZZ

K863280 is an FDA 510(k) premarket notification submitted by Dermacare Products, Inc. for the device "DERMAMARKER". The FDA issued a decision of Substantially Equivalent on September 9, 1986. The device falls under product code FZZ (Marker, Skin), a Class I device regulated under 21 CFR 878.4660. Dermacare Products, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1986
Date Received
August 25, 1986
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 Dermacare Products, Inc.

  • K882494 — ELAN-E DISPOSALBE DRAPE (July 8, 1988)
  • K882421 — INFANT ELECTROSURGICAL DISPERSIVE ELECTRODE (June 30, 1988)
  • K871910 — SURGITEK DISPOSABLE BIPOLAR CORD (June 1, 1987)
  • K863279 — SURGI-TEK TUBE POSITIONER (September 9, 1986)
  • K863278 — SURGI-WIPES (September 2, 1986)
  • K862367 — PRO-CLEAN (July 8, 1986)
  • K853374 — CORRECT-A-COUNT (September 5, 1985)

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)
  • K861772 — LASER SKIN MARKER AND MASK WHITE LOTION (May 21, 1986)
  • K844865 — SECURLINE SURGICAL SKIN MARKER 1000 (January 14, 1985)

FDA data resources