Sunrise 6200, Sunrise 7200— 510(k) K173565
Substantially EquivalentJk-Holding GmbH
FDA 510(k) clearance K173565 for Sunrise 6200, Sunrise 7200, Substantially Equivalent on 2018-02-14. Applicant: Jk-Holding GmbH. Device class: 2.
Clearance details
- Applicant
- Jk-Holding GmbH
- Product code
- Code LEJ
- Device class
- Class 2
- Regulation
- 21 CFR 878.4635
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Windhagen, DE
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