The following data is part of a premarket notification filed by Covidien Lp, Formerly Registered As Kendall with the FDA for Dobbhoff Dual Port Feeding Tube.
Device ID | K112511 |
510k Number | K112511 |
Device Name: | DOBBHOFF DUAL PORT FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
Contact | Debora Stapleton |
Correspondent | Debora Stapleton COVIDIEN LP, FORMERLY REGISTERED AS KENDALL 15 HAMPSHIRE ST. Mansfield, MA 02048 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-08-30 |
Decision Date | 2012-05-11 |
Summary: | summary |