The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Flexiflo Laparoscopic Gastrostomy Kit.
| Device ID | K924697 |
| 510k Number | K924697 |
| Device Name: | FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ABBOTT LABORATORIES 625 CLEVELAND AVE. Columbus, OH 43215 |
| Contact | Daniel Hamilton |
| Correspondent | Daniel Hamilton 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 | 1992-09-17 |
| Decision Date | 1993-08-27 |