Alphamedix I/A Hand-Piece, 500-001
FDA 510(k) K830812 · Alphamedix, Inc.
510(k) numberK830812
Submission
- Device name
- Alphamedix I/A Hand-Piece, 500-001
- Applicant
- Alphamedix, Inc.
Mchenry, IL, US - Received
- March 15, 1983
- Decision date
- June 8, 1983
- 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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|---|---|---|
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| K851272 | VersaphageHQE · Traditional | 07/05/1985SE |
| K830703 | GlomarkFZZ · Traditional | 04/28/1983SE |
| K820363 | Disposable Surgical GarmentsFYA · Traditional | 03/08/1982SE |
| K820008 | Versatome IHQE · Traditional | 02/22/1982SE |
Questions and answers
When was Alphamedix I/A Hand-Piece, 500-001 cleared by the FDA?
Alphamedix I/A Hand-Piece, 500-001 (K830812) received a 510(k) decision of Substantially Equivalent on June 8, 1983, 85 days after the submission was received.
What is the product code of K830812?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.