The following data is part of a premarket notification filed by C.r. Bard Inc with the FDA for Ponsky* Non-balloon Replacement Gastrostomy Tube.
| Device ID | K103109 |
| 510k Number | K103109 |
| Device Name: | PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | C.R. BARD INC 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Contact | Dennis Salzmann |
| Correspondent | Dennis Salzmann C.R. BARD INC 605 NORTH 5600 WEST Salt Lake City, UT 84116 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-21 |
| Decision Date | 2010-12-22 |
| Summary: | summary |