The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Cutter Pureflo Plus Iv Filter.
| Device ID | K872634 |
| 510k Number | K872634 |
| Device Name: | CUTTER PUREFLO PLUS IV FILTER |
| Classification | Filter, Infusion Line |
| Applicant | MILES LABORATORIES, INC. 4TH & PARKER ST. POST OFFICE BOX 1986 Berkeley, CA 94701 |
| Contact | M Sternberg |
| Correspondent | M Sternberg 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 | 1987-07-06 |
| Decision Date | 1987-08-04 |