KETAC-CEM IN REF. TO K802048— 510(k) K802819
Substantially EquivalentEspe Dental Products
FDA 510(k) clearance K802819 for KETAC-CEM IN REF. TO K802048, Substantially Equivalent on 1980-11-24. Applicant: Espe Dental Products. Device class: 2.
Clearance details
- Applicant
- Espe Dental Products
- Product code
- Code EMA
- Device class
- Class 2
- Regulation
- 21 CFR 872.3275
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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