D-KAT Z-YPE— 510(k) K142179

Substantially Equivalent

Keeler, Ltd.

FDA 510(k) clearance K142179 for D-KAT Z-YPE, Substantially Equivalent on 2014-09-17. Applicant: Keeler, Ltd.. Device class: 2.

Clearance details

Applicant: Keeler, Ltd.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2014-08-08
Decision date: 2014-09-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Broomall, PA, US

Download summary PDF View on FDA.gov ↗

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