510(k) K110853
K110853 is an FDA 510(k) premarket notification submitted by Vr Medical for the device "VR MEDICAL ENTERAL ORAL SYRINGE". The FDA issued a decision of Substantially Equivalent on May 13, 2011. The device falls under product code FPD (Tube, Feeding), a Class II device regulated under 21 CFR 876.5980. Vr Medical has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 13, 2011
- Date Received
- March 28, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Tube, Feeding
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type