GATEWAY ADVANAGE Y-ADAPTER— 510(k) K130909
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K130909 for GATEWAY ADVANAGE Y-ADAPTER, Substantially Equivalent on 2013-05-16. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code OCX
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.