ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5.— 510(k) K090157

Name: FDA 510(k) clearance K090157
Creator: U.S. Food and Drug Administration
Published: 2009-05-04

Substantially Equivalent

Wcm Waste & Compliance Management, Inc.

FDA 510(k) clearance K090157 for ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5., Substantially Equivalent on 2009-05-04. Applicant: Wcm Waste & Compliance Management, Inc.. Device class: 2.

Clearance details

Applicant: Wcm Waste & Compliance Management, Inc.
Product code: Code MMK
Device class: Class 2
Regulation: 21 CFR 880.5570
Advisory panel: General Hospital
Date received: 2009-01-22
Decision date: 2009-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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