Minitube Dentasleeve Protective Barrier Sleeves— 510(k) K211026
Substantially EquivalentMinitube AB
FDA 510(k) clearance K211026 for Minitube Dentasleeve Protective Barrier Sleeves, Substantially Equivalent on 2021-08-03. Applicant: Minitube AB. Device class: 2.
Clearance details
- Applicant
- Minitube AB
- 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
- Trångsviken, SE
Recent devices under product code PEM
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