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 | K172247 |
510k Number | K172247 |
Device Name: | Magic3 Go Intermittent Urinary Catheter |
Classification | Catheter, Straight |
Applicant | C.R. Bard, Inc. 8195 Industrial Blvd Covington, GA 30014 |
Contact | Nancy Underwood |
Correspondent | Nancy Underwood 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 | 2017-07-26 |
Decision Date | 2017-09-20 |
Summary: | summary |