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ISOLYSER HOME SHARPS MANAGEMENT - Isoly Sharps Management System (sms), Models 2400m, 4000m, 10000m, 5.

FDA 510(k)

Class II (US FDA 510(k))

510(k) K090157

by Wcm Waste & Compliance Management, Inc.

Identifiers

510(k) Number
K090157 FDA 510(k)
FDA Product Code
MMK FDA 510(k)
Models / Variants
Isolyser Home Sharps Management (hsm), Model 800m FDA 510(k)
Isoly Sharps Management System (sms), Models 2400m, 4000m, 10000m, 5. FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.5570 FDA 510(k)
Regulation Number
880.5570 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

ISOLYSER HOME SHARPS MANAGEMENT - Isoly Sharps Management System (sms), Models 2400m, 4000m, 10000m, 5. by Wcm Waste & Compliance Management, Inc. — Class II…

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wcm Waste & Compliance Management, Inc.

Sources (1)

  • FDA 510(k) K090157 24 fields · synced Jun 19, 2026