ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.— 510(k) K822240

Name: FDA 510(k) clearance K822240
Creator: U.S. Food and Drug Administration
Published: 1982-12-30

Substantially Equivalent

American Mcgaw

FDA 510(k) clearance K822240 for ETHYLENE OXIDE STERILIZ. PARAMETRIC REL., Substantially Equivalent on 1982-12-30. Applicant: American Mcgaw. Device class: 2.

Clearance details

Applicant: American Mcgaw
Product code: Code KFX
Device class: Class 2
Regulation: 21 CFR 890.3500
Advisory panel: Physical Medicine
Date received: 1982-07-27
Decision date: 1982-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

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