BIOMATT-1— 510(k) K841392
Substantially EquivalentBiorec Us, Inc.
FDA 510(k) clearance K841392 for BIOMATT-1, Substantially Equivalent on 1985-01-18. Applicant: Biorec Us, Inc.. Device class: 2.
Clearance details
- Applicant
- Biorec Us, Inc.
- Product code
- Code BZQ
- Device class
- Class 2
- Regulation
- 21 CFR 868.2375
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lagrange Park, IL, US
Recent devices under product code BZQ
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