REPROCESSED FEMORAL COMPRESSION DEVICE— 510(k) K120204

Name: FDA 510(k) clearance K120204
Creator: U.S. Food and Drug Administration
Published: 2012-04-03

Substantially Equivalent

Sterilmed, Inc.

FDA 510(k) clearance K120204 for REPROCESSED FEMORAL COMPRESSION DEVICE, Substantially Equivalent on 2012-04-03. Applicant: Sterilmed, Inc.. Device class: 2.

Clearance details

Applicant: Sterilmed, Inc.
Product code: Code NMF
Device class: Class 2
Regulation: 21 CFR 870.4450
Advisory panel: Cardiovascular
Date received: 2012-01-23
Decision date: 2012-04-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Maple Grove, MN, US

Download summary PDF View on FDA.gov ↗

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