ACCUTIP COVER— 510(k) K132549

Substantially Equivalent

Accutome, Inc.

FDA 510(k) clearance K132549 for ACCUTIP COVER, Substantially Equivalent on 2014-04-23. Applicant: Accutome, Inc.. Device class: 2.

Clearance details

Applicant: Accutome, Inc.
Product code: Code HKY
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2013-08-14
Decision date: 2014-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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