CELSITE, MODELS ST401L, ST405L
FDA 510(k) clearance K994111 · decided 2000-01-03
Clearance details
- K-number
- K994111
- Device name
- CELSITE, MODELS ST401L, ST405L
- Applicant
- B. Braun/Mcgaw
- Decision
- Substantially Equivalent
- Date received
- 1999-12-06
- Decision date
- 2000-01-03
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Allentown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.