Site Anterior Capsulotomer
FDA 510(k) K843039 · Chiron Vision Corp.
510(k) numberK843039
Submission
- Device name
- Site Anterior Capsulotomer
- Applicant
- Chiron Vision Corp.
Irvine, CA, US - Received
- August 2, 1984
- Decision date
- November 21, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMX – Cannula, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4350
- Specialty
- Ophthalmic
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Questions and answers
When was Site Anterior Capsulotomer cleared by the FDA?
Site Anterior Capsulotomer (K843039) received a 510(k) decision of Substantially Equivalent on November 21, 1984, 111 days after the submission was received.
What is the product code of K843039?
The FDA product code is HMX – Cannula, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.4350.