1ST IMPRESSION— 510(k) K921571
Substantially EquivalentWykle Research, Inc.
FDA 510(k) clearance K921571 for 1ST IMPRESSION, Substantially Equivalent on 1993-09-10. Applicant: Wykle Research, Inc.. Device class: 2.
Clearance details
- Applicant
- Wykle Research, 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
- Carson City, NV, US
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