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510(k) K833457

ETHYLENE OXIDE GAS STERILIZA SYS II by Ben Venue Laboratories, Inc. — Product Code FLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1983
Date Received
October 5, 1983
Clearance Type
Traditional
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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