The following data is part of a premarket notification filed by Bd Medical Surgical with the FDA for Bd Oral/enteral Syringe With Bd Univia Connection.
| Device ID | K112434 |
| 510k Number | K112434 |
| Device Name: | BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | BD MEDICAL SURGICAL ONE BECTON DR. MC237 Franklin Lakes, NJ 07417 -1880 |
| Contact | John Roberts |
| Correspondent | John Roberts BD MEDICAL SURGICAL ONE BECTON DR. MC237 Franklin Lakes, NJ 07417 -1880 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-24 |
| Decision Date | 2011-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50382903058636 | K112434 | 000 |
| 50382903028363 | K112434 | 000 |
| 50382903028370 | K112434 | 000 |
| 50382903058513 | K112434 | 000 |
| 50382903058537 | K112434 | 000 |
| 50382903058551 | K112434 | 000 |
| 50382903058575 | K112434 | 000 |
| 50382903058599 | K112434 | 000 |
| 50382903058612 | K112434 | 000 |
| 50382903024358 | K112434 | 000 |