Uc-Care Warming System
FDA 510(k) K090978 · UC-CARE , Ltd.
510(k) numberK090978
Submission
- Device name
- Uc-Care Warming System
- Applicant
- UC-CARE , Ltd.
Washington, DC, US - Received
- April 6, 2009
- Decision date
- August 10, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEH – Unit, Cryosurgical, Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4350
- Specialty
- General, Plastic Surgery
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Questions and answers
When was Uc-Care Warming System cleared by the FDA?
Uc-Care Warming System (K090978) received a 510(k) decision of Substantially Equivalent on August 10, 2009, 126 days after the submission was received.
What is the product code of K090978?
The FDA product code is GEH – Unit, Cryosurgical, Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4350.