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510(k) K903962

INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE by Apk Technology — Product Code LRP

K903962 is an FDA 510(k) premarket notification submitted by Apk Technology for the device "INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE". The FDA issued a decision of Substantially Equivalent (kit, denovo) on July 29, 1991. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800. Apk Technology has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
July 29, 1991
Date Received
August 28, 1990
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 Apk Technology

  • K903963 — KITS AND TRAYS FOR ONE TIME USE ONLY (July 29, 1991)

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)
  • K905462 — PROCEDURE TRAY/FOR VARIOUS OPHTHALMIC PROCEDURES (February 6, 1991)

FDA data resources