510(k) K901791
K901791 is an FDA 510(k) premarket notification submitted by Southside Biotechnology for the device "PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING CATH.". The FDA issued a decision of Substantially Equivalent (kit) on August 8, 1990. The device falls under product code KGC (Tube, Gastro-Enterostomy), a Class II device regulated under 21 CFR 876.5980. Southside Biotechnology has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- August 8, 1990
- Date Received
- April 19, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Gastro-Enterostomy
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type