The following data is part of a premarket notification filed by Vesco Medical, Llc with the FDA for Vesco Medical Nasoenteric Feeding Tubes.
Device ID | K170162 |
510k Number | K170162 |
Device Name: | Vesco Medical Nasoenteric Feeding Tubes |
Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
Applicant | Vesco Medical, LLC 692 N. High Street, Suite 205 Columbus, OH 43215 |
Contact | Chris O'keefe |
Correspondent | Rachel Kunzweiler Vesco Medical, LLC 692 N. High Street, Suite 205 Columbus, OH 43215 |
Product Code | PIF |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-01-18 |
Decision Date | 2017-09-26 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850002550986 | K170162 | 000 |
00850002550979 | K170162 | 000 |
10850002550372 | K170162 | 000 |
10850002550365 | K170162 | 000 |
10850002550358 | K170162 | 000 |
10850002550280 | K170162 | 000 |
10850801006193 | K170162 | 000 |