510(k) K905016
K905016 is an FDA 510(k) premarket notification submitted by Davol, Inc. for the device "PEDIATRIC AND INFANT CATH KITS". The FDA issued a decision of Substantially Equivalent (with conditions) on December 20, 1990. The device falls under product code FFH (Collector, Urine, Pediatric, For Indwelling Catheter), a Class II device regulated under 21 CFR 876.5250. Davol, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- December 20, 1990
- Date Received
- November 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collector, Urine, Pediatric, For Indwelling Catheter
- Device Class
- Class II
- Regulation Number
- 876.5250
- Review Panel
- GU
- Submission Type