Sunivf Dishes
FDA 510(k) K080395 · <Genx> Intl., Inc.
510(k) numberK080395
Submission
- Device name
- Sunivf Dishes
- Applicant
- <Genx> Intl., Inc.
Gilford, CT, US - Received
- February 13, 2008
- Decision date
- August 13, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MQK – Labware, Assisted Reproduction
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6160
- Specialty
- Obstetrics/Gynecology
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Questions and answers
When was Sunivf Dishes cleared by the FDA?
Sunivf Dishes (K080395) received a 510(k) decision of Substantially Equivalent on August 13, 2008, 182 days after the submission was received.
What is the product code of K080395?
The FDA product code is MQK – Labware, Assisted Reproduction, a Class II (moderate risk) device regulated under 21 CFR 884.6160.