The following data is part of a premarket notification filed by Benlan, Inc. with the FDA for Med-rx Oral/enteral Syringe.
| Device ID | K131183 |
| 510k Number | K131183 |
| Device Name: | MED-RX ORAL/ENTERAL SYRINGE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | BENLAN, INC. 2760 BRIGHTON RD. Oakville, Ontario, CA L6h 5t4 |
| Contact | Cheryl Brown |
| Correspondent | Cheryl Brown BENLAN, INC. 2760 BRIGHTON RD. Oakville, Ontario, CA L6h 5t4 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-26 |
| Decision Date | 2014-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50628725005039 | K131183 | 000 |
| 00628725003740 | K131183 | 000 |
| 00628725003757 | K131183 | 000 |
| 00628725003764 | K131183 | 000 |
| 00628725003771 | K131183 | 000 |
| 00628725003788 | K131183 | 000 |
| 00628725003795 | K131183 | 000 |
| 00628725003856 | K131183 | 000 |
| 50628725004971 | K131183 | 000 |
| 50628725004988 | K131183 | 000 |
| 00628725004990 | K131183 | 000 |
| 50628725005008 | K131183 | 000 |
| 50628725005015 | K131183 | 000 |
| 50628725005022 | K131183 | 000 |
| 50628725005435 | K131183 | 000 |