The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Balloon Dilation Kit With Trifunnel Gastrostomy Tube.
| Device ID | K063118 |
| 510k Number | K063118 |
| Device Name: | BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Contact | Susan Scott |
| Correspondent | Susan Scott C.R. BARD, INC. 5425 WEST AMELIA EARHART DR. Salt Lake City, UT 84116 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-11 |
| Decision Date | 2007-02-13 |
| Summary: | summary |