The following data is part of a premarket notification filed by Mcgaw, Inc. with the FDA for Millennium Crt Infusion Pump And Millennium Crt Infusion Pump Administration Sets.
| Device ID | K972678 |
| 510k Number | K972678 |
| Device Name: | MILLENNIUM CRT INFUSION PUMP AND MILLENNIUM CRT INFUSION PUMP ADMINISTRATION SETS |
| Classification | Pump, Infusion |
| Applicant | MCGAW, INC. 2525 MCGAW AVE. Irvine, CA 92714 -5895 |
| Contact | Rebecca Stolarick |
| Correspondent | Rebecca Stolarick MCGAW, INC. 2525 MCGAW AVE. Irvine, CA 92714 -5895 |
| Product Code | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-16 |
| Decision Date | 1997-10-07 |
| Summary: | summary |