The following data is part of a premarket notification filed by Benlan, Inc. with the FDA for Med-rx Transfer Set, Models 10-1227ts, 10-1300ts, 10-1305ts And 10-1306ts.
| Device ID | K102073 |
| 510k Number | K102073 |
| Device Name: | MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS |
| Classification | Set, Administration, Intravascular |
| Applicant | BENLAN, INC. P.O. BOX 4341 Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith BENLAN, INC. P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-23 |
| Decision Date | 2010-11-08 |
| Summary: | summary |