Barrier Sleeves— 510(k) K191448
Substantially EquivalentIvoclar Vivadent, AG
FDA 510(k) clearance K191448 for Barrier Sleeves, Substantially Equivalent on 2019-10-08. Applicant: Ivoclar Vivadent, AG. Device class: 2.
Clearance details
- Applicant
- Ivoclar Vivadent, AG
- Product code
- Code PEM
- Device class
- Class 2
- Regulation
- 21 CFR 878.4370
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Schaan, LI
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