ETHYLENE OXIDE GAS STERILIZA SYS II— 510(k) K833457

Name: FDA 510(k) clearance K833457
Creator: U.S. Food and Drug Administration
Published: 1983-12-29

Substantially Equivalent

Ben Venue Laboratories, Inc.

FDA 510(k) clearance K833457 for ETHYLENE OXIDE GAS STERILIZA SYS II, Substantially Equivalent on 1983-12-29. Applicant: Ben Venue Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Ben Venue Laboratories, Inc.
Product code: Code FLF
Device class: Class 2
Regulation: 21 CFR 880.6860
Advisory panel: General Hospital
Date received: 1983-10-05
Decision date: 1983-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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