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510(k) K873290

LACERATION AND INSTRUMENT TRAYS by Advantage Medical Systems, Inc. — Product Code LRP

K873290 is an FDA 510(k) premarket notification submitted by Advantage Medical Systems, Inc. for the device "LACERATION AND INSTRUMENT TRAYS". The FDA issued a decision of Substantially Equivalent on September 24, 1987. The device falls under product code LRP (Tray, Surgical), a Class I device regulated under 21 CFR 878.4800. Advantage Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 1987
Date Received
August 17, 1987
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 Advantage Medical Systems, Inc.

  • K873957 — NON-CORING HUBER TYPE NEEDLES (October 23, 1987)
  • K863494 — NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 (December 22, 1986)
  • K861556 — MODIFIED FETAL MONITOR MODEL FM-2 (July 7, 1986)
  • K861279 — FLUORO PLUS (June 16, 1986)
  • K861455 — MODEL DT-102 DATA TELEPHONE TRANSMITTER (May 30, 1986)
  • K852518 — MODIFICATION FETAL MONITOR MODEL FM-2 (July 5, 1985)
  • K844724 — FETAL TELEMETRY SYSTEM (May 1, 1985)
  • K842462 — HOLTER SCREENING MONITOR HS-221 (September 11, 1984)
  • K840747 — TOCO DATA TELEPHONE TRANSMITTER DT100P (June 19, 1984)
  • K832849 — FETAL MONITOR #FM-2 (October 4, 1983)

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