The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Labeling Change For Cutter Pureflo Plus Iv Filter.
| Device ID | K880605 |
| 510k Number | K880605 |
| Device Name: | LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER |
| Classification | Filter, Infusion Line |
| Applicant | MILES LABORATORIES, INC. 4TH & PARKER ST. POST OFFICE BOX 1986 Berkeley, CA 94701 |
| Contact | Sternberg, Phd |
| Correspondent | Sternberg, Phd MILES LABORATORIES, INC. 4TH & PARKER ST. POST OFFICE BOX 1986 Berkeley, CA 94701 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-12 |
| Decision Date | 1988-05-26 |