GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL— 510(k) K030414
Substantially EquivalentSultan Chemists, Inc.
FDA 510(k) clearance K030414 for GENIE ULTRA HYDROPHILIC IMPRESSION MATERIAL, Substantially Equivalent on 2003-04-09. Applicant: Sultan Chemists, Inc.. Device class: 2.
Clearance details
- Applicant
- Sultan Chemists, Inc.
- Product code
- 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
- Englewood, NJ, US
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