PuraSinus— 510(k) K183015

Substantially Equivalent

3-D Matrix, Inc.

FDA 510(k) clearance K183015 for PuraSinus, Substantially Equivalent on 2019-04-12. Applicant: 3-D Matrix, Inc..

Clearance details

Applicant: 3-D Matrix, Inc.
Product code: Code NHB
Advisory panel: Ear, Nose, Throat
Date received: 2018-10-31
Decision date: 2019-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, US

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