510(k) K923983
K923983 is an FDA 510(k) premarket notification submitted by Sandoz Nutrition for the device "PEG GUIDEWIRE SYSTEM GASTROSTOMY TUBE KIT". The FDA issued a decision of Substantially Equivalent on Apr 6, 1993. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Sandoz Nutrition has 19 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 6, 1993
- Date Received
- Aug 7, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Tubes, Gastrointestinal (And Accessories)
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
- 510(k)