EAR SURGERY SPECULUM— 510(k) K822373

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K822373 for EAR SURGERY SPECULUM, Substantially Equivalent on 1982-09-09. Applicant: Treace Medical, Inc.. Device class: 1.

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code EPY
Device class: Class 1
Regulation: 21 CFR 878.1800
Advisory panel: General, Plastic Surgery
Date received: 1982-08-06
Decision date: 1982-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EPY

K950086 — PEDIA PALS, INCORPORATED1995-02-07
K925754 — ECONOM1993-10-08
K853588 — FIBRELIGHT NASAL SPECULA1985-12-18
K834189 — JAKOBI SURG. INSTRUMENTS #7 44/471984-03-06
K822370 — UNIVERSAL SPECULUM HOLDER1982-09-09

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.