LC TEMPORARY FILLING— 510(k) K012360
Substantially EquivalentParkell, Inc.
FDA 510(k) clearance K012360 for LC TEMPORARY FILLING, Substantially Equivalent on 2001-09-06. Applicant: Parkell, Inc.. Device class: 2.
Clearance details
- Applicant
- Parkell, Inc.
- Product code
- Code EBG
- Device class
- Class 2
- Regulation
- 21 CFR 872.3770
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Farmingdale, NY, US
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