The following data is part of a premarket notification filed by Abbvie Inc. with the FDA for Abbvie Peg.
Device ID | K133087 |
510k Number | K133087 |
Device Name: | ABBVIE PEG |
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 | No |
Date Received | 2013-09-30 |
Decision Date | 2014-06-19 |
Summary: | summary |