Instru-Safe Instrument Protection System— 510(k) K150540

Name: FDA 510(k) clearance K150540
Creator: U.S. Food and Drug Administration
Published: 2015-06-22

Substantially Equivalent

Summit Medical, Inc.

FDA 510(k) clearance K150540 for Instru-Safe Instrument Protection System, Substantially Equivalent on 2015-06-22. Applicant: Summit Medical, Inc.. Device class: 2.

Clearance details

Applicant: Summit Medical, Inc.
Product code: Code KCT
Device class: Class 2
Regulation: 21 CFR 880.6850
Advisory panel: General Hospital
Date received: 2015-03-03
Decision date: 2015-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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