The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Gauderer Universal Percutaneous Endoscopic.
| Device ID | K915841 |
| 510k Number | K915841 |
| Device Name: | BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | C.R. BARD, INC. 111 SPRING ST. Murray Hill, NJ 07974 |
| Contact | Rowland Williams |
| Correspondent | Rowland Williams C.R. BARD, INC. 111 SPRING ST. Murray Hill, NJ 07974 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-24 |
| Decision Date | 1993-06-25 |