UNICEM HM— 510(k) K100908
Substantially Equivalent3M Espe AG Dental Products
FDA 510(k) clearance K100908 for UNICEM HM, Substantially Equivalent on 2010-06-22. Applicant: 3M Espe AG Dental Products. Device class: 2.
Clearance details
- Applicant
- 3M Espe AG 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
- Bavaria D-82228 Seefeld, DE
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