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510(k) K890165

FORCEPS-ORTHOPEDIC by Dhason Brothers, Inc. — Product Code LXN

K890165 is an FDA 510(k) premarket notification submitted by Dhason Brothers, Inc. for the device "FORCEPS-ORTHOPEDIC". The FDA issued a decision of Substantially Equivalent on February 13, 1989. The device falls under product code LXN (Probe, Test, Heart-Valve), a Class I device regulated under 21 CFR 870.4500. Dhason Brothers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1989
Date Received
January 9, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Probe, Test, Heart-Valve
Device Class
Class I
Regulation Number
870.4500
Review Panel
CV
Submission Type

Other clearances by Dhason Brothers, Inc.

  • K890162 — EXTRACTOR FOR AUSTIN MOORE FEMORAL HEAD (February 13, 1989)
  • K890166 — RONGUER-ORTHOPEDIC (February 13, 1989)
  • K890158 — RETRACTORS (February 13, 1989)
  • K890156 — IMPACTOR FOR FEMORAL HEAD (February 13, 1989)
  • K890163 — AUSTIN MOORE HALLOW CHISEL (February 13, 1989)
  • K890164 — HUDSON BRACE W/BURRS (February 13, 1989)
  • K890168 — RETRACTOR, SELF-RETAINING (February 13, 1989)
  • K890160 — GOUGES FOR FEMORAL HEADS (February 13, 1989)
  • K890161 — THOMPSON TYPE RASP W/TOMMY BAR (February 13, 1989)
  • K890157 — FORCEPS (February 13, 1989)

Other clearances for product code LXN

  • K881449 — EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 (June 15, 1988)

FDA data resources