The following data is part of a premarket notification filed by Benlan Inc with the FDA for Med-rx Patient Delivery Set.
| Device ID | K120375 |
| 510k Number | K120375 |
| Device Name: | MED-RX PATIENT DELIVERY SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BENLAN INC 2760 BRIGHTON RD Oakville, CA L6h 5t4 |
| Contact | Cheryl Brown |
| Correspondent | Cheryl Brown BENLAN INC 2760 BRIGHTON RD Oakville, CA L6h 5t4 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-06 |
| Decision Date | 2012-06-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628725003931 | K120375 | 000 |
| 00628725003924 | K120375 | 000 |
| 00628725003344 | K120375 | 000 |
| 00628725003306 | K120375 | 000 |