LASIK EYE DRAPE— 510(k) K042977

Substantially Equivalent

Odyssey Medical, Inc.

FDA 510(k) clearance K042977 for LASIK EYE DRAPE, Substantially Equivalent on 2005-05-10. Applicant: Odyssey Medical, Inc.. Device class: 2.

Clearance details

Applicant: Odyssey Medical, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2004-10-28
Decision date: 2005-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Memphis, TN, US

Download summary PDF View on FDA.gov ↗

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