Plasdent Disposable Barrier Sleeves and Barrier Film— 510(k) K201604
Substantially EquivalentPlasdent Corporation
FDA 510(k) clearance K201604 for Plasdent Disposable Barrier Sleeves and Barrier Film, Substantially Equivalent on 2020-12-23. Applicant: Plasdent Corporation. Device class: 2.
Clearance details
- Applicant
- Plasdent Corporation
- 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
- Pomona, CA, US
Recent devices under product code PEM
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