The following data is part of a premarket notification filed by Abbvie Inc. with the FDA for Abbvie Nj.
Device ID | K142792 |
510k Number | K142792 |
Device Name: | AbbVie NJ |
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 - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | Yes |
Date Received | 2014-09-26 |
Decision Date | 2015-01-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
38054083008302 | K142792 | 000 |