MIRROR TIP— 510(k) K823915

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K823915 for MIRROR TIP, Substantially Equivalent on 1983-01-21. Applicant: Treace Medical, Inc.. Device class: 1.

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code KAI
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 1982-12-28
Decision date: 1983-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KAI

K833601 — ANTRUM & ATTIC MIRROR1984-01-03
K822374 — BUCKINGHAM ATTIC & ANTRUM MIRROR1982-09-09
K822261 — LARYNGEAL MIRRORS1982-08-30
K822191 — HEAD MIRROR WITH HEADBAND1982-08-20
K820354 — ATMOS MIRROR WARMER1982-03-01

More clearances from Treace Medical, Inc.

K883727 — BUCKET PROSTHESIS PORP1989-01-13
K882349 — MALLET, SURGICAL1988-06-23
K874779 — BIPOLATOR 501988-01-29
K873154 — TREACE MAGNUM OTO-TOOL SYSTEM1987-09-04
K872000 — EYE GARD1987-07-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.