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K Number
K962755
Device Name
STRYKER ENCORE STERILIZER
Manufacturer
STRYKER CORP.
Date Cleared
1997-03-04

(231 days)

Product Code
FLE
Regulation Number
880.6880
Type
Traditional
Panel
General Hospital
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 880.6880 Steam sterilizer.

(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).