ALLROUND 55 LF— 510(k) K001260
Substantially EquivalentJ.F. Jelenko & Co., Inc.
FDA 510(k) clearance K001260 for ALLROUND 55 LF, Substantially Equivalent on 2000-05-17. Applicant: J.F. Jelenko & Co., Inc.. Device class: 2.
Clearance details
- Applicant
- J.F. Jelenko & Co., Inc.
- Product code
- Code EJT
- Device class
- Class 2
- Regulation
- 21 CFR 872.3060
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Armonk, NY, US
Recent devices under product code EJT
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