510(k) K903545
K903545 is an FDA 510(k) premarket notification submitted by J.J. Skinner, Inc. for the device "CAREKITS(TM), IV/CATH/CENT LINE DRESS/TPN/CVP KITS". The FDA issued a decision of Substantially Equivalent (kit, denovo) on November 13, 1990. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. J.J. Skinner, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SEKD (Substantially Equivalent (kit, denovo))
- Decision Date
- November 13, 1990
- Date Received
- August 6, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5200
- Review Panel
- HO
- Submission Type