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510(k) K896792

SURGICAL SKIN MARKER by Westmark, Sterile Packing Systems, Inc. (Sps) — Product Code FZZ

K896792 is an FDA 510(k) premarket notification submitted by Westmark, Sterile Packing Systems, Inc. (Sps) for the device "SURGICAL SKIN MARKER". The FDA issued a decision of Substantially Equivalent on December 27, 1989. The device falls under product code FZZ (Marker, Skin), a Class I device regulated under 21 CFR 878.4660. Westmark, Sterile Packing Systems, Inc. (Sps) has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 27, 1989
Date Received
December 1, 1989
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 Westmark, Sterile Packing Systems, Inc. (Sps)

  • K896800 — IRRIGATION TRAY (May 24, 1990)
  • K896799 — PARACERVICAL/PUDENDAL TRAYS (April 23, 1990)
  • K896559 — INFANT FEEDING TUBE (March 13, 1990)
  • K896794 — SPECIMEN CONTAINER (March 1, 1990)
  • K896806 — CATHETER PLUG/PROTECTOR (February 26, 1990)
  • K896798 — TRACHEOSTOMY TRAY (February 22, 1990)
  • K896797 — SUCTION CATHETER KIT (February 16, 1990)
  • K896215 — MERCY HIP/KNEE PACK (February 13, 1990)
  • K896804 — MANIFOLD (February 8, 1990)
  • K896556 — UNIVERSAL POOLE SUCTION TUBE (February 6, 1990)

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)
  • 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