SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)— 510(k) K123653
Substantially EquivalentBisco, Inc.
FDA 510(k) clearance K123653 for SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED), Substantially Equivalent on 2013-06-03. Applicant: Bisco, Inc.. Device class: 2.
Clearance details
- Applicant
- Bisco, Inc.
- Product code
- Code LBH
- Device class
- Class 2
- Regulation
- 21 CFR 872.3260
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Schaumburg, IL, US
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