HUMAN II LENS— 510(k) K781927

Substantially Equivalent

Spectra-Shield, Inc.

FDA 510(k) clearance K781927 for HUMAN II LENS, Substantially Equivalent on 1978-12-20. Applicant: Spectra-Shield, Inc.. Device class: 1.

Clearance details

Applicant: Spectra-Shield, Inc.
Product code: Code HQG
Device class: Class 1
Regulation: 21 CFR 886.5844
Advisory panel: Ophthalmic
Date received: 1978-11-16
Decision date: 1978-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HQG

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K900091 — MODIFIED OPHTHALMIC OPIR ONUFRYK IMAGE DEFLECTOR1990-04-04
K884360 — SEIKO P-6 PROGRESSIVE SPECTACLE LENSES1988-11-15
K882814 — NEOLENS PRESCRIPTION SPECTACLE LENS1988-07-29

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