Cleared Traditional

K854613 - SURGICAL DRAPES, OPHTHALMIN
(FDA 510(k) Clearance)

K854613 · Charles Atkins & Co. · General Hospital
Feb 1986
Decision
87d
Days
Class 2
Risk

K854613 is an FDA 510(k) clearance for the SURGICAL DRAPES, OPHTHALMIN. This device is classified as a Drape, Patient, Ophthalmic (Class II — Special Controls, product code HMT).

Submitted by Charles Atkins & Co. (Atlanta, US). The FDA issued a Cleared decision on February 13, 1986, 87 days after receiving the submission on November 18, 1985.

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

Submission Details

510(k) Number K854613 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 1985
Decision Date February 13, 1986
Days to Decision 87 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