The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Latex Urinary Catheters.
Device ID | K922431 |
510k Number | K922431 |
Device Name: | BARD LATEX URINARY CATHETERS |
Classification | Catheter, Urological |
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 | KOD |
CFR Regulation Number | 876.5130 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-05-22 |
Decision Date | 1993-03-25 |