The following data is part of a premarket notification filed by Biomedical Dynamics, Inc. with the FDA for Correct Flo Intravascular Administration Set.
| Device ID | K850506 |
| 510k Number | K850506 |
| Device Name: | CORRECT FLO INTRAVASCULAR ADMINISTRATION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BIOMEDICAL DYNAMICS, INC. 3800 MULTIFOODS TOWER 33 SOUTH SIXTH STREET Minneapolis, MN 55402 |
| Contact | Poindexter, Jacobson |
| Correspondent | Poindexter, Jacobson BIOMEDICAL DYNAMICS, INC. 3800 MULTIFOODS TOWER 33 SOUTH SIXTH STREET Minneapolis, MN 55402 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-08 |
| Decision Date | 1985-04-01 |