510(k) K963779
K963779 is an FDA 510(k) premarket notification submitted by Rusch, Inc. for the device "RUSCH ENTERAL FEEDING TUBE". The FDA issued a decision of Substantially Equivalent on May 23, 1997. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Rusch, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1997
- Date Received
- September 20, 1996
- 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