The following data is part of a premarket notification filed by Microvasive with the FDA for Jejunal Feeding Tube.
Device ID | K861309 |
510k Number | K861309 |
Device Name: | JEJUNAL FEEDING TUBE |
Classification | Tubes, Gastrointestinal (and Accessories) |
Applicant | MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
Contact | Samuel D Wade |
Correspondent | Samuel D Wade MICROVASIVE 31 MAPLE ST. Milford, MA 01757 |
Product Code | KNT |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-08 |
Decision Date | 1986-12-16 |