EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
FDA 510(k) clearance K002705 · decided 2001-03-28
Clearance details
- K-number
- K002705
- Device name
- EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400
- Applicant
- Baxa Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-08-30
- Decision date
- 2001-03-28
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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