Cleared Traditional

K841515 - SCANLAN VASCU-STATT II
(FDA 510(k) Clearance)

K841515 · Scanlan Intl., Inc. · Ophthalmic device

Jun 1984

Decision

54d

Days

Class 1

Risk

K841515 is an FDA 510(k) clearance for the SCANLAN VASCU-STATT II. This device is classified as a Engine, Trephine, Accessories, Ac-powered (Class I - General Controls, product code HRG).

Submitted by Scanlan Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 5, 1984, 54 days after receiving the submission on April 12, 1984.

This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4070.

Submission Details

510(k) Number	K841515 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 12, 1984
Decision Date	June 05, 1984
Days to Decision	54 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—