ASEPTYLUM, UNI-CARRIER— 510(k) K961714
Substantially EquivalentDistriflor S.A.
FDA 510(k) clearance K961714 for ASEPTYLUM, UNI-CARRIER, Substantially Equivalent on 1996-06-10. Applicant: Distriflor S.A.. Device class: 1.
Clearance details
- Applicant
- Distriflor S.A.
- Product code
- Code EKJ
- Device class
- Class 1
- Regulation
- 21 CFR 872.4565
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sandy, UT, US
Recent devices under product code EKJ
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