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510(k) K014013

H & W HOSPITAL ETHYLENE OXIDE STERILIZER CONTROL SYSTEM by H & W Technology, LLC — Product Code FLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2003
Date Received
December 5, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Ethylene-Oxide Gas
Device Class
Class II
Regulation Number
880.6860
Review Panel
HO
Submission Type

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