The following data is part of a premarket notification filed by Ross Product Div. Abbott Laboratories with the FDA for Modification To Flexflo Polyg Gastrostomy Tube.
| Device ID | K990863 |
| 510k Number | K990863 |
| Device Name: | MODIFICATION TO FLEXFLO POLYG GASTROSTOMY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ROSS PRODUCT DIV. ABBOTT LABORATORIES 625 CLEVELAND AVE. Columbus, OH 43215 -1724 |
| Contact | Daniel Hamilton |
| Correspondent | Daniel Hamilton ROSS PRODUCT DIV. ABBOTT LABORATORIES 625 CLEVELAND AVE. Columbus, OH 43215 -1724 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-16 |
| Decision Date | 1999-04-06 |