InSure ONE— 510(k) K170548

Substantially Equivalent

Enterix, Inc.

FDA 510(k) clearance K170548 for InSure ONE, Substantially Equivalent on 2017-10-05. Applicant: Enterix, Inc..

Clearance details

Applicant: Enterix, Inc.
Product code: Code KHE
Advisory panel: Hematology
Date received: 2017-02-24
Decision date: 2017-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

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