COLTOLUX LIGHT METER— 510(k) K950106
Substantially EquivalentColtene/Whaledent, Inc.
FDA 510(k) clearance K950106 for COLTOLUX LIGHT METER, Substantially Equivalent on 1995-05-24. Applicant: Coltene/Whaledent, Inc.. Device class: 2.
Clearance details
- Applicant
- Coltene/Whaledent, 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
- Mahwah, NJ, US
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