Modification to Ciba Vision Centurion Ses Spikeratome
FDA 510(k) K032978 · Ciba Vision Corporation
510(k) numberK032978
Submission
- Device name
- Modification to Ciba Vision Centurion Ses Spikeratome
- Applicant
- Ciba Vision Corporation
Duluth, GA, US - Received
- September 24, 2003
- Decision date
- October 20, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HNO – Keratome, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4370
- Specialty
- Ophthalmic
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Questions and answers
When was Modification to Ciba Vision Centurion Ses Spikeratome cleared by the FDA?
Modification to Ciba Vision Centurion Ses Spikeratome (K032978) received a 510(k) decision of Substantially Equivalent on October 20, 2003, 26 days after the submission was received.
What is the product code of K032978?
The FDA product code is HNO – Keratome, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 886.4370.