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510(k) K890071

STERILE LACERATION TRAY by Mumtaz I. Malik — Product Code LRP

K890071 is an FDA 510(k) premarket notification submitted by Mumtaz I. Malik for the device "STERILE LACERATION TRAY". The FDA issued a decision of Substantially Equivalent on January 24, 1989. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800. Mumtaz I. Malik has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1989
Date Received
January 9, 1989
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 Mumtaz I. Malik

  • K901511 — CHISEL, BONE, SURGICAL (September 28, 1990)
  • K901289 — RONGEUR, ORTHOPEDIC SURGICAL INSTRUMENTS (September 28, 1990)
  • K901521 — OSTEOTOMES OF VARIOUS TYPES (September 28, 1990)
  • K901420 — VOLKMAN BONE CURRETTE 5, 5-3/4, 6-3/4, 8 (September 28, 1990)
  • K893902 — 4 X 4 STERILE GAUZE SPONGE TRAY (July 14, 1989)
  • K884195 — GENERAL SURGICAL INSTRUMENTS (VARIOUS TYPES) (October 24, 1988)

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