EndoArmor + Surgical Gown— 510(k) K203548
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K203548 for EndoArmor + Surgical Gown, Substantially Equivalent on 2022-02-21. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code FYA
- Device class
- Class 2
- Regulation
- 21 CFR 878.4040
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Marlboro, MA, US
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More clearances from Boston Scientific Corporation
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