CASTLE MODEL 233HC STEAM STERILIZER

K003441 · Getinge/Castle, Inc. · FLE · Jan 2, 2001 · General Hospital

Device Facts

Record IDK003441
Device NameCASTLE MODEL 233HC STEAM STERILIZER
ApplicantGetinge/Castle, Inc.
Product CodeFLE · General Hospital
Decision DateJan 2, 2001
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 880.6880
Device ClassClass 2

Regulatory Classification

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.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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