Seal Single Use Biopsy Valve— 510(k) K182275
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K182275 for Seal Single Use Biopsy Valve, Substantially Equivalent on 2018-09-13. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- 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
- Special
- Location
- Marlboro, MA, US
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