PUREtrace— 510(k) K153262

Substantially Equivalent

Nemo Healthcare BV

FDA 510(k) clearance K153262 for PUREtrace, Substantially Equivalent on 2017-02-07. Applicant: Nemo Healthcare BV.

Clearance details

Applicant: Nemo Healthcare BV
Product code: Code OSP
Advisory panel: Obstetrics/Gynecology
Date received: 2015-11-10
Decision date: 2017-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Veldhoven, NL

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