Cleared Traditional

K871706 - OPTHA PREP
(FDA 510(k) Clearance)

K871706 · Treace Medical, Inc. · General Hospital
May 1987
Decision
17d
Days
Class 2
Risk

K871706 is an FDA 510(k) clearance for the OPTHA PREP. This device is classified as a Drape, Patient, Ophthalmic (Class II — Special Controls, product code HMT).

Submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on May 18, 1987, 17 days after receiving the submission on May 1, 1987.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.4370.

Submission Details

510(k) Number K871706 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1987
Decision Date May 18, 1987
Days to Decision 17 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code HMT — Drape, Patient, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4370