Reprocessed Electrophysiology Diagnostic Catheters— 510(k) K150357

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K150357 for Reprocessed Electrophysiology Diagnostic Catheters, Substantially Equivalent on 2015-08-27. Applicant: Sterilmed, Inc..

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code NLH
Advisory panel: Cardiovascular
Date received: 2015-02-12
Decision date: 2015-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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