The following data is part of a premarket notification filed by Ziehm International, Inc. with the FDA for Iv Administration Sets - Mvp Infusion.
| Device ID | K830453 |
| 510k Number | K830453 |
| Device Name: | IV ADMINISTRATION SETS - MVP INFUSION |
| Classification | Set, Administration, Intravascular |
| Applicant | ZIEHM INTERNATIONAL, INC. 906-A COMMERCE RD. Annapolis, MD 21401 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-15 |
| Decision Date | 1983-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28500042541005 | K830453 | 000 |
| 18500042541213 | K830453 | 000 |
| 18500042541008 | K830453 | 000 |