The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Urodynamic Catheter.
Device ID | K924714 |
510k Number | K924714 |
Device Name: | BARD URODYNAMIC CATHETER |
Classification | Device, Cystometric, Hydraulic |
Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
Contact | Donna J Wilson |
Correspondent | Donna J Wilson C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
Product Code | FEN |
CFR Regulation Number | 876.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-09-21 |
Decision Date | 1993-09-21 |