The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Button Replacement Gastrostomy Device.
| Device ID | K904779 |
| 510k Number | K904779 |
| Device Name: | BUTTON REPLACEMENT GASTROSTOMY DEVICE |
| Classification | Tube, Gastro-enterostomy |
| Applicant | C.R. BARD, INC. ONE PARK WEST Tewksbury, MA 01876 -1234 |
| Contact | Ernest Manfredo |
| Correspondent | Ernest Manfredo C.R. BARD, INC. ONE PARK WEST Tewksbury, MA 01876 -1234 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-22 |
| Decision Date | 1991-01-18 |