The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Dignishield Stool Management System.
| Device ID | K133251 |
| 510k Number | K133251 |
| Device Name: | BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Michele Davis |
| Correspondent | Michele Davis C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-22 |
| Decision Date | 2014-05-09 |
| Summary: | summary |