POLY-LITE MODEL 1000— 510(k) K954061
Substantially EquivalentPro-Den Systems, Inc.
FDA 510(k) clearance K954061 for POLY-LITE MODEL 1000, Substantially Equivalent on 1995-09-21. Applicant: Pro-Den Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Pro-Den Systems, Inc.
- Product code
- Code EBZ
- Device class
- Class 2
- Regulation
- 21 CFR 872.6070
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Vancouver, WA, US
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