The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Needleless Transfer Device, Models: M285503 And M285505.
| Device ID | K092246 |
| 510k Number | K092246 |
| Device Name: | NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Contact | Jessica Oswald |
| Correspondent | Jessica Oswald NIPRO MEDICAL CORPORATION 3150 N.W. 107TH AVE. Miami, FL 33172 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-28 |
| Decision Date | 2009-11-12 |
| Summary: | summary |