510(k) K990236
MODIFICATION OF JELCO*,JELCO*-W AND JELCO* PLUS I.V. CATHETERS, CATHLON* I.V. CATHETERS, OPTIVA* I.V. CATHETERS, PROTECT by
Johnson & Johnson Medical, Div. of Ethicon, Inc.
— Product Code FOZ
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 20, 1999
- Date Received
- January 25, 1999
- 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