Cleared Traditional

K831621 - FLUORETS STERILE OPHTH. STRIPS (FDA 510(k) Clearance)

K831621 · Smith & Nephew, Inc. · Ophthalmic device

Jul 1983

Decision

60d

Days

—

Risk

K831621 is an FDA 510(k) clearance for the FLUORETS STERILE OPHTH. STRIPS..

Submitted by Smith & Nephew, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983, 60 days after receiving the submission on May 19, 1983.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number	K831621 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 19, 1983
Decision Date	July 18, 1983
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	—

Device Classification

Product Code	KYC
Device Class	—