The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Hydrogel-coated Urethral Catheters And Drains.
| Device ID | K910197 |
| 510k Number | K910197 |
| Device Name: | HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS |
| Classification | Catheter, Coude |
| 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 | EZC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-16 |
| Decision Date | 1991-08-09 |