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510(k) K931872

THE EAGLE 3017 100% ETHYLENE OXIDE STERILIZER by American Sterilizer Co. — Product Code FLF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1994
Date Received
April 14, 1993
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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  • K905816 — ORTHOVISION TABLE (March 6, 1991)
  • K896674 — AMSCO QUANTUM LIGHT (January 3, 1990)
  • K895164 — EAGLE DS (November 17, 1989)
  • K882660 — GENERAL SURGICAL TABLE AND ACCESSORIES (July 25, 1988)
  • K880198 — GEMINI SURGICAL LIGHT (February 10, 1988)
  • K864846 — RADIOGRAPHIC - LEG SECTION (December 24, 1986)
  • K844479 — CHEMSPOR (November 25, 1985)

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