T-TYPE D-KAT, R-TYPE D-KAT— 510(k) K133234

Substantially Equivalent

Keeler Limited

FDA 510(k) clearance K133234 for T-TYPE D-KAT, R-TYPE D-KAT, Substantially Equivalent on 2014-02-21. Applicant: Keeler Limited. Device class: 2.

Clearance details

Applicant: Keeler Limited
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2013-10-21
Decision date: 2014-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Broomall, PA, US

Download summary PDF View on FDA.gov ↗

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