SCLERAL SHELL— 510(k) K970327

Substantially Equivalent

Southwest Artificial Eyes, Inc.

FDA 510(k) clearance K970327 for SCLERAL SHELL, Substantially Equivalent on 1997-07-07. Applicant: Southwest Artificial Eyes, Inc.. Device class: 2.

Clearance details

Applicant: Southwest Artificial Eyes, Inc.
Product code: Code HQT
Device class: Class 2
Regulation: 21 CFR 886.3800
Advisory panel: Ophthalmic
Date received: 1997-01-28
Decision date: 1997-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQT

K970320 — SCLERAL SHELL1997-07-07
K904961 — ARTIFICIAL SCLERAL SHELL1991-08-30
K855105 — SIMMONS SHELL1986-03-31

More clearances from Southwest Artificial Eyes, Inc.

K970318 — OCULAR CONFORMER1997-07-07

Data sourced from openFDA. This site is unofficial and independent of the FDA.