The following data is part of a premarket notification filed by Abbvie Inc. with the FDA for Abbvie J.
| Device ID | K142816 |
| 510k Number | K142816 |
| Device Name: | AbbVie J |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ABBVIE INC. 1 N. WAUKEGAN RD. North Chicago, IL 60064 |
| Contact | Katherine Wortley |
| Correspondent | Katherine Wortley ABBVIE INC. 1 N. WAUKEGAN RD. North Chicago, IL 60064 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2014-09-29 |
| Decision Date | 2015-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942149162 | K142816 | 000 |
| 10889942149155 | K142816 | 000 |
| 28054083004918 | K142816 | 000 |
| 08054083014432 | K142816 | 000 |
| 08054083004907 | K142816 | 000 |
| 08054083004884 | K142816 | 000 |
| 08054083004860 | K142816 | 000 |