Intercassette, Interkit, Universal Pak & Cassette
FDA 510(k) K890300 · CooperVision, Inc.
510(k) numberK890300
Submission
- Device name
- Intercassette, Interkit, Universal Pak & Cassette
- Applicant
- CooperVision, Inc.
Irvine, CA, US - Received
- January 19, 1989
- Decision date
- April 17, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4150
- Specialty
- Ophthalmic
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| K033390 | Colibri Disposable Vitrectomy CutterHQE · Traditional | Microworld Medical Instruments, Inc. | 11/04/2003SE |
| K030948 | Vmate Model VMM1000HQE · Traditional | Howard Instruments, Inc. | 06/17/2003SE |
| K023939 | Velocity AdvantageHQE · Traditional | Visioncare Devices, Inc. | 04/17/2003SE |
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| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…LPL · Traditional | 03/23/2020SE |
| K190965 | MyDayLPL · Special | 04/29/2019SE |
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| K133627 | Avaira Spheric and Toric (Enfilcon a) Soft Contact LensLPL · Special | 12/23/2013SE |
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Questions and answers
When was Intercassette, Interkit, Universal Pak & Cassette cleared by the FDA?
Intercassette, Interkit, Universal Pak & Cassette (K890300) received a 510(k) decision of Substantially Equivalent on April 17, 1989, 88 days after the submission was received.
What is the product code of K890300?
The FDA product code is HQE – Instrument, Vitreous Aspiration And Cutting, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.4150.