SILICOATER MD— 510(k) K910719
Substantially EquivalentKulzer, Inc.
FDA 510(k) clearance K910719 for SILICOATER MD, Substantially Equivalent on 1991-04-29. Applicant: Kulzer, Inc.. Device class: 2.
Clearance details
- Applicant
- Kulzer, Inc.
- 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
- Irvine, CA, US
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