The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for 0.2 U Bacterial Filter.
| Device ID | K974661 |
| 510k Number | K974661 |
| Device Name: | 0.2 U BACTERIAL FILTER |
| Classification | Filter, Infusion Line |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Product Code | FPB |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-15 |
| Decision Date | 1998-02-11 |
| Summary: | summary |