UMBILI-CATH-P
FDA 510(k) clearance K940871 · decided 1994-04-29
Clearance details
- K-number
- K940871
- Device name
- UMBILI-CATH-P
- Applicant
- Gesco Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-02-25
- Decision date
- 1994-04-29
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- FOS
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.