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510(k) K760497

TRAY, SERVICE by Landmark Plastics — Product Code LRP

K760497 is an FDA 510(k) premarket notification submitted by Landmark Plastics for the device "TRAY, SERVICE". The FDA issued a decision of Substantially Equivalent on November 12, 1976. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800. Landmark Plastics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1976
Date Received
August 23, 1976
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 Landmark Plastics

  • K760490 — BEDPAN, GENERAL MEDICAL MEDI-PAK (November 12, 1976)
  • K760517 — CUP, DISPOSABLE MEDICINE (November 12, 1976)
  • K760548 — CARAFE AND LINER (November 12, 1976)
  • K760493 — DISH, SOAP (November 12, 1976)
  • K760495 — BASIN, RECTANGULAR WASH (November 12, 1976)
  • K760552 — THERMOMETER STAND AND DUST COVER (November 12, 1976)
  • K760496 — CUP, DISPOSABLE SPECIMEN (November 12, 1976)
  • K760492 — BASIN, LARGE OR SMALL (November 12, 1976)
  • K760494 — BASIN, ROUND WASH (November 12, 1976)
  • K760491 — TUMBLER, GENERAL MEDICAL MEDI-PAK (September 15, 1976)

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)
  • 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)

FDA data resources