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510(k) K963723

LACERATION TRAY by Grand Medical Products — Product Code LRP

K963723 is an FDA 510(k) premarket notification submitted by Grand Medical Products for the device "LACERATION TRAY". The FDA issued a decision of Substantially Equivalent on November 27, 1996. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800. Grand Medical Products has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1996
Date Received
September 16, 1996
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 Grand Medical Products

  • K963724 — GAUZE SPONGE, NON X-RAY DETECTABLE (November 29, 1996)
  • K963721 — SKIN SCRUB TRAY (November 27, 1996)
  • K963719 — CENTRAL LINE DRESSING CHANGE TRAY, TPN/CVP DRESSING CHANGE TRAY (November 27, 1996)
  • K963720 — TRACHEOSTOMY KIT (November 27, 1996)
  • K963715 — DEBRIDEMENT TRAY, INCISION AND DRAINAGE TRAY (November 27, 1996)
  • K963722 — IV START KIT (November 27, 1996)
  • K963714 — GRAND MEDICAL SUTURE REMOVAL KIT (November 27, 1996)

Other clearances for product code LRP

  • 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)
  • K903962 — INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE (July 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