The following data is part of a premarket notification filed by Benlan, Inc. with the FDA for Med-rx Extension Sets.
| Device ID | K990777 |
| 510k Number | K990777 |
| Device Name: | MED-RX EXTENSION SETS |
| Classification | Set, Administration, Intravascular |
| Applicant | BENLAN, INC. 2760 BRIGHTON RD. Oakville, Ontario, CA L6h 5t4 |
| Contact | Bill C.k. Lim |
| Correspondent | Bill C.k. Lim BENLAN, INC. 2760 BRIGHTON RD. Oakville, Ontario, 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 | 1999-03-09 |
| Decision Date | 1999-08-25 |
| Summary: | summary |