The following data is part of a premarket notification filed by Inrad with the FDA for Iv Decanter-flexible.
| Device ID | K980587 |
| 510k Number | K980587 |
| Device Name: | IV DECANTER-FLEXIBLE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | INRAD 3956 44TH ST., S.E. Kentwood, MI 49512 |
| Contact | Anne Armstrong |
| Correspondent | Anne Armstrong INRAD 3956 44TH ST., S.E. Kentwood, MI 49512 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-17 |
| Decision Date | 1998-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10817295020555 | K980587 | 000 |