SMARTSPONGE PLUS SYSTEM— 510(k) K073180

Name: FDA 510(k) clearance K073180
Creator: U.S. Food and Drug Administration
Published: 2007-11-19

Substantially Equivalent

Clearcount Medical Solutions, Inc.

FDA 510(k) clearance K073180 for SMARTSPONGE PLUS SYSTEM, Substantially Equivalent on 2007-11-19. Applicant: Clearcount Medical Solutions, Inc.. Device class: 1.

Clearance details

Applicant: Clearcount Medical Solutions, Inc.
Product code: Code LWH
Device class: Class 1
Regulation: 21 CFR 880.2740
Advisory panel: General Hospital
Date received: 2007-11-13
Decision date: 2007-11-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, US

Download summary PDF View on FDA.gov ↗

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