The following data is part of a premarket notification filed by Disetronic Medical Systems Ag with the FDA for Disetronic Rapid Subcutaneous Infusion Set And Disteronic Rapid D Subcutaneous Infusion Set.
| Device ID | K003977 |
| 510k Number | K003977 |
| Device Name: | DISETRONIC RAPID SUBCUTANEOUS INFUSION SET AND DISTERONIC RAPID D SUBCUTANEOUS INFUSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | DISETRONIC MEDICAL SYSTEMS AG 5151 PROGRAM AVE. St. Paul, MN 55112 -1014 |
| Contact | David E Chadwick |
| Correspondent | David E Chadwick DISETRONIC MEDICAL SYSTEMS AG 5151 PROGRAM AVE. St. Paul, MN 55112 -1014 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-22 |
| Decision Date | 2001-02-15 |