SMALL MASTOID RETRACTOR— 510(k) K870758

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K870758 for SMALL MASTOID RETRACTOR, Substantially Equivalent on 1987-03-04. Applicant: Treace Medical, Inc.. Device class: 1.

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code KAL
Device class: Class 1
Regulation: 21 CFR 874.4420
Advisory panel: Ear, Nose, Throat
Date received: 1987-02-26
Decision date: 1987-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KAL

K833604 — ADJUSTABLE FORK RETRACTOR1984-01-03
K772381 — RING HANDLE & RETRACTORS1978-01-17
K772392 — ALLPORT MASTOID RETRACTORS1978-01-17
K760851 — CONVERSE ALTAR RETRACTOR1977-03-10

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.