510(k) K791372
K791372 is an FDA 510(k) premarket notification submitted by Jelco Laboratories for the device "JELCO & KVO CATHETER PLACEMENT UNIT". The FDA issued a decision of Substantially Equivalent on September 12, 1979. The device falls under product code JCY (Catheter, Infusion), a Class I device regulated under 21 CFR 878.4200. Jelco Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1979
- Date Received
- July 24, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Infusion
- Device Class
- Class I
- Regulation Number
- 878.4200
- Review Panel
- SU
- Submission Type