510(k) K940871
K940871 is an FDA 510(k) premarket notification submitted by Gesco Intl., Inc. for the device "UMBILI-CATH-P". The FDA issued a decision of Substantially Equivalent on April 29, 1994. The device falls under product code FOS (Catheter, Umbilical Artery), a Class II device regulated under 21 CFR 880.5200. Gesco Intl., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 1994
- Date Received
- February 25, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Umbilical Artery
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type