MICRO21 WITH NDNA— 510(k) K964165
Substantially EquivalentTriangle Biomedical Sciences, Inc.
FDA 510(k) clearance K964165 for MICRO21 WITH NDNA, Substantially Equivalent on 1997-01-03. Applicant: Triangle Biomedical Sciences, Inc.. Device class: 2.
Clearance details
- Applicant
- Triangle Biomedical Sciences, Inc.
- Product code
- Code DHN
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Beach Gardens, FL, US
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