The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Flexiflo Introducer (direct Stick) Gastrostomy Kit.
| Device ID | K884275 |
| 510k Number | K884275 |
| Device Name: | FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY 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 - With Drug (SESD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-10-12 |
| Decision Date | 1988-12-22 |