Cavitron/Kelman Phaco-Emulsifier Aspirator, 9001
FDA 510(k) K852271 · CooperVision, Inc.
510(k) numberK852271
Submission
- Device name
- Cavitron/Kelman Phaco-Emulsifier Aspirator, 9001
- Applicant
- CooperVision, Inc.
Irvine, CA, US - Received
- May 28, 1985
- Decision date
- August 9, 1985
- 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 |
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| K191763 | MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A)…LPL · Traditional | 03/23/2020SE |
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Questions and answers
When was Cavitron/Kelman Phaco-Emulsifier Aspirator, 9001 cleared by the FDA?
Cavitron/Kelman Phaco-Emulsifier Aspirator, 9001 (K852271) received a 510(k) decision of Substantially Equivalent on August 9, 1985, 73 days after the submission was received.
What is the product code of K852271?
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.