Disposable Barrier Sleeves and Covers— 510(k) K160232
Substantially EquivalentDentsply International, Inc.
FDA 510(k) clearance K160232 for Disposable Barrier Sleeves and Covers, Substantially Equivalent on 2016-06-07. Applicant: Dentsply International, Inc.. Device class: 2.
Clearance details
- Applicant
- Dentsply International, Inc.
- 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
- York, PA, US
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