COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC— 510(k) K912485
Substantially EquivalentColtene/Whaledent, Inc.
FDA 510(k) clearance K912485 for COLTENE PRESIDENT JET LIGHT/REG BODY HYDROPHILIC, Substantially Equivalent on 1991-07-25. Applicant: Coltene/Whaledent, Inc.. Device class: 2.
Clearance details
- Applicant
- Coltene/Whaledent, Inc.
- Product code
- Product code ELW
- Device class
- Class 2
- Regulation
- 21 CFR 872.3660
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New York, NY, US
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