STERILE EYE SURGERY KITS— 510(k) K842990

Name: FDA 510(k) clearance K842990
Creator: U.S. Food and Drug Administration
Published: 1985-05-09

Substantially Equivalent

Biological & Environmental Control Laboratories

FDA 510(k) clearance K842990 for STERILE EYE SURGERY KITS, Substantially Equivalent on 1985-05-09. Applicant: Biological & Environmental Control Laboratories. Device class: 2.

Clearance details

Applicant: Biological & Environmental Control Laboratories
Product code: Code HOZ
Device class: Class 2
Regulation: 21 CFR 886.4790
Advisory panel: Ophthalmic
Date received: 1984-07-30
Decision date: 1985-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, US

Download summary PDF View on FDA.gov ↗

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