BACTASHIELD— 510(k) K811859
Substantially EquivalentTri-Med, Inc.
FDA 510(k) clearance K811859 for BACTASHIELD, Substantially Equivalent on 1981-08-07. Applicant: Tri-Med, Inc.. Device class: 2.
Clearance details
- Applicant
- Tri-Med, Inc.
- Product code
- Code FIB
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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