The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Magic3 Go Intermittent Urinary Catheter.
| Device ID | K150345 |
| 510k Number | K150345 |
| Device Name: | Magic3 Go Intermittent Urinary Catheter |
| Classification | Catheter, Straight |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington, GA 30014 |
| Contact | William Heard |
| Correspondent | William Heard C.R. BARD, INC. 8195 INDUSTRIAL BLVD Covington, GA 30014 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-11 |
| Decision Date | 2015-05-11 |
| Summary: | summary |