The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Uroforce Balloon Dilation Catheter.
| Device ID | K993840 |
| 510k Number | K993840 |
| Device Name: | BARD UROFORCE BALLOON DILATION CATHETER |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Angela L Bunn |
| Correspondent | Angela L Bunn C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-12 |
| Decision Date | 2000-01-31 |
| Summary: | summary |