510(k) K001916
K001916 is an FDA 510(k) premarket notification submitted by Novartis Nutrition Corp. for the device "COMPAT REPLACEMENT GASTROSTOMY TUBE KIT, MODEL 0974XX". The FDA issued a decision of Substantially Equivalent on February 16, 2001. The device falls under product code KNT (Tubes, Gastrointestinal (And Accessories)), a Class II device regulated under 21 CFR 876.5980. Novartis Nutrition Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2001
- Date Received
- June 23, 2000
- 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