Site Ultrasonic Emulsification Module Op
FDA 510(k) K844666 · Chiron Vision Corp.
510(k) numberK844666
Submission
- Device name
- Site Ultrasonic Emulsification Module Op
- Applicant
- Chiron Vision Corp.
Irvine, CA, US - Received
- November 30, 1984
- Decision date
- December 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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Questions and answers
When was Site Ultrasonic Emulsification Module Op cleared by the FDA?
Site Ultrasonic Emulsification Module Op (K844666) received a 510(k) decision of Substantially Equivalent on December 27, 1984, 27 days after the submission was received.
What is the product code of K844666?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.