510(k) K110853

VR MEDICAL ENTERAL ORAL SYRINGE by Vr Medical — Product Code FPD

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