KOWA SC-1200 PHOTO SLIT LAMP SYSTEM— 510(k) K955442

Name: FDA 510(k) clearance K955442
Creator: U.S. Food and Drug Administration
Published: 1996-01-03

Substantially Equivalent

Kowa Optimed, Inc.

FDA 510(k) clearance K955442 for KOWA SC-1200 PHOTO SLIT LAMP SYSTEM, Substantially Equivalent on 1996-01-03. Applicant: Kowa Optimed, Inc.. Device class: 2.

Clearance details

Applicant: Kowa Optimed, Inc.
Product code: Code HKI
Device class: Class 2
Regulation: 21 CFR 886.1120
Advisory panel: Ophthalmic
Date received: 1995-11-28
Decision date: 1996-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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