The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Flexiflo Laparoscopic Jejunostomy Kit.
| Device ID | K925102 |
| 510k Number | K925102 |
| Device Name: | FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ABBOTT LABORATORIES 625 CLEVELAND AVE. Columbus, OH 43215 |
| Contact | Michael H Haney |
| Correspondent | Michael H Haney ABBOTT LABORATORIES 625 CLEVELAND AVE. Columbus, OH 43215 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-08 |
| Decision Date | 1994-06-09 |