510(k) K912575
K912575 is an FDA 510(k) premarket notification submitted by Sandoz Nutrition for the device "EXTERNAL GASTROSTOMY TUBE RETAINER". The FDA issued a decision of Substantially Equivalent on Nov 21, 1991. The device falls under product code FPD (Tube, Feeding), 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
- Nov 21, 1991
- Date Received
- Jun 12, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Tube, Feeding
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type
- 510(k)