FLOSTAT VASCULAR LAB— 510(k) K973644
Substantially EquivalentBiomedix, Inc.
FDA 510(k) clearance K973644 for FLOSTAT VASCULAR LAB, Substantially Equivalent on 1997-12-23. Applicant: Biomedix, Inc.. Device class: 2.
Clearance details
- Applicant
- Biomedix, Inc.
- Product code
- Code JAF
- Device class
- Class 2
- Regulation
- 21 CFR 892.1540
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Camden, NJ, US
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