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510(k) K940646

ORTHOPEDIC TRAY PRODUCT LINE by Cushindu — Product Code LRP

K940646 is an FDA 510(k) premarket notification submitted by Cushindu for the device "ORTHOPEDIC TRAY PRODUCT LINE". The FDA issued a decision of Substantially Equivalent (kit, denovo) on March 11, 1994. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
March 11, 1994
Date Received
February 15, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tray, Surgical
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

Other clearances for product code LRP

  • K963723 — LACERATION TRAY (November 27, 1996)
  • K951811 — OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK (May 31, 1995)
  • K940239 — EYE TRAY (June 28, 1994)
  • K935621 — CUSTOM ENT PACKS (March 30, 1994)
  • K940444 — GENERAL SURGERY TRAY (March 7, 1994)
  • K922126 — HOSPITAL KIT ENT 1125 (January 21, 1993)
  • K912105 — EYE TRAY (August 29, 1991)
  • K903963 — KITS AND TRAYS FOR ONE TIME USE ONLY (July 29, 1991)
  • K903962 — INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE (July 29, 1991)
  • K905462 — PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (February 6, 1991)

FDA data resources