Modification to the Site Peristaltic Module System
FDA 510(k) K883199 · Chiron Vision Corp.
510(k) numberK883199
Submission
- Device name
- Modification to the Site Peristaltic Module System
- Applicant
- Chiron Vision Corp.
Horsham, PA, US - Received
- July 28, 1988
- Decision date
- September 15, 1988
- 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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| K944995 | Iolab/Site Peristaltic ModuleHQC · Traditional | 10/05/1995SE |
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Questions and answers
When was Modification to the Site Peristaltic Module System cleared by the FDA?
Modification to the Site Peristaltic Module System (K883199) received a 510(k) decision of Substantially Equivalent on September 15, 1988, 49 days after the submission was received.
What is the product code of K883199?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.