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510(k) K940239

EYE TRAY by Cush Medical Products — Product Code LRP

K940239 is an FDA 510(k) premarket notification submitted by Cush Medical Products for the device "EYE TRAY". The FDA issued a decision of Substantially Equivalent (kit, denovo) on June 28, 1994. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800. Cush Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
June 28, 1994
Date Received
January 19, 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 by Cush Medical Products

  • K943424 — CUSH ISLAND DRESSING (October 3, 1994)
  • K940518 — C-SECTION TRAY (August 18, 1994)
  • K941349 — DENTAL TRAY (July 26, 1994)
  • K941645 — BIOPSY TRAY (July 14, 1994)
  • K935684 — IV START KIT (June 10, 1994)
  • K941455 — STERILE GAUZE PRODUCT LINE (May 20, 1994)
  • K941522 — STERILE X-RAY DETECTABLE GAUZE SPONGES (May 12, 1994)
  • K941344 — LAP SPONGE PRODUCT LINE (May 12, 1994)
  • K935697 — CIRCUMCISION TRAY (May 2, 1994)
  • K936120 — LABOR AND DELIVERY TRAY (March 30, 1994)

Other clearances for product code LRP

  • K963723 — LACERATION TRAY (November 27, 1996)
  • K951811 — OSTEOTECH MUSCULOSKELETAL TISSUE RECOVERY PACK (May 31, 1995)
  • K935621 — CUSTOM ENT PACKS (March 30, 1994)
  • K940646 — ORTHOPEDIC TRAY PRODUCT LINE (March 11, 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