Reprocessed Steerable Introducer— 510(k) K152090

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K152090 for Reprocessed Steerable Introducer, Substantially Equivalent on 2016-03-23. Applicant: Sterilmed, Inc..

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code PNE
Advisory panel: Cardiovascular
Date received: 2015-07-27
Decision date: 2016-03-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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