FDA 510(k)

ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000

K-Number: K090156 · 2009-09-01

ApplicantWcm Waste & Compliance Management, Inc.

Decision Date2009-09-01

Product CodeFMI

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 is the device name listed in this FDA 510(k) record. The listed applicant is Wcm Waste & Compliance Management, Inc.. It received FDA 510(k) clearance on 2009-09-01 under 510(k) number K090156. The device is classified under product code FMI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000?

ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 is a medical device that received FDA 510(k) clearance on 2009-09-01. The listed applicant is Wcm Waste & Compliance Management, Inc.. The 510(k) number is K090156.

When did ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 receive FDA 510(k) clearance?

ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 received FDA 510(k) clearance on 2009-09-01, under 510(k) number K090156.

Who is the listed applicant for ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000?

The FDA 510(k) record lists Wcm Waste & Compliance Management, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000?

The FDA product code for ISOLYSER SHARPS ROOM SYSTEM, MODEL 800; ISOLYSER SHARPS MANAGEMENT SYSTEM, MODELS 2400, 4000, 10000 is FMI.

Related Clinical Trials

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Other records listing Wcm Waste & Compliance Management, Inc. as applicant

K090157ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHARPS MANAGEMENT SYSTEM (SMS), MODELS 2400M, 4000M, 10000M, 5.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.