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510(k) K915066

DISPOSABLE SKIN MARKER by American Medical Mfg., Inc. — Product Code FZZ

K915066 is an FDA 510(k) premarket notification submitted by American Medical Mfg., Inc. for the device "DISPOSABLE SKIN MARKER". The FDA issued a decision of Substantially Equivalent on May 14, 1992. The device falls under product code FZZ (Marker, Skin), a Class I device regulated under 21 CFR 878.4660. American Medical Mfg., Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1992
Date Received
November 8, 1991
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 American Medical Mfg., Inc.

  • K982029 — SHARPS COLLECTION CONTAINER - SAF-T-SHELL (April 6, 1999)
  • K961454 — AMMI MAGNI-GUARD (July 25, 1996)
  • K915064 — DISPOSABLE CAUTERY ABRASIVE PAD (March 11, 1992)
  • K915065 — I.V.IRRIGATION POLE (February 11, 1992)
  • K915068 — PLASTIC DISPOSABLE SURGICAL LIGHT HANDLE COVER (February 6, 1992)

Other clearances for product code FZZ

  • K042555 — SURGICHIP TAG SURGICAL MARKER (November 9, 2004)
  • 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