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510(k) K882275

STERILE PACK (PROCEDURAL TRAY/KITS) by East Texas Lighthouse For the Blind — Product Code LRP

K882275 is an FDA 510(k) premarket notification submitted by East Texas Lighthouse For the Blind for the device "STERILE PACK (PROCEDURAL TRAY/KITS)". The FDA issued a decision of Substantially Equivalent on July 18, 1988. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800. East Texas Lighthouse For the Blind has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1988
Date Received
May 31, 1988
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 East Texas Lighthouse For the Blind

  • K883376 — STERILIZATION WRAP TYPE 22,44,77 (September 28, 1988)
  • K863733 — TOWEL PACK, SURGICAL (October 14, 1986)
  • K862062 — NONWOVEN SURGICAL DRAPE PACK (June 10, 1986)
  • K850067 — MEDICAL, DISPOSABLE BEDDING (April 19, 1985)
  • K850811 — PAD, PRE-OPERATIVE PREPARATION (March 21, 1985)
  • K850016 — TOWEL PACK, SURGICAL (January 23, 1985)

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)
  • K903962 — INSTRUMENTS FOR ONE TIME USE/ DISPOSABLE (July 29, 1991)
  • K903963 — KITS AND TRAYS FOR ONE TIME USE ONLY (July 29, 1991)

FDA data resources