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510(k) K830703

GLOMARK by Alphamedix, Inc. — Product Code FZZ

K830703 is an FDA 510(k) premarket notification submitted by Alphamedix, Inc. for the device "GLOMARK". The FDA issued a decision of Substantially Equivalent on April 28, 1983. The device falls under product code FZZ (Marker, Skin), a Class I device regulated under 21 CFR 878.4660. Alphamedix, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 1983
Date Received
March 7, 1983
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 Alphamedix, Inc.

  • K852633 — VERSABLADE (November 4, 1985)
  • K852706 — VERSABLADE (November 4, 1985)
  • K851272 — VERSAPHAGE (July 5, 1985)
  • K830812 — ALPHAMEDIX I/A HAND-PIECE, 500-001 (June 8, 1983)
  • K820363 — DISPOSABLE SURGICAL GARMENTS (March 8, 1982)
  • K820008 — VERSATOME I (February 22, 1982)

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