OPTHA PREP— 510(k) K871706

Substantially Equivalent

Treace Medical, Inc.

FDA 510(k) clearance K871706 for OPTHA PREP, Substantially Equivalent on 1987-05-18. Applicant: Treace Medical, Inc.. Device class: 2.

Clearance details

Applicant: Treace Medical, Inc.
Product code: Code HMT
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1987-05-01
Decision date: 1987-05-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HMT

K945738 — VISIFLEX OPHTHALMIC SURGICAL INCISE DRAPE1995-02-14
K905460 — STERILE DISPOSABLE DRAPE/OPHTHALMIC SURGERY1991-02-06
K872620 — SOLOS EYESITE DRAPES1987-07-31
K854613 — SURGICAL DRAPES, OPHTHALMIN1986-02-13
K831340 — DRAIN-R-DRAPE(EYE1983-06-08

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.