The following data is part of a premarket notification filed by Biomedix, Inc. with the FDA for Biomedix I.v. Extension Line W/ Stopcock Model B50-102/b51-102.
| Device ID | K961928 |
| 510k Number | K961928 |
| Device Name: | BIOMEDIX I.V. EXTENSION LINE W/ STOPCOCK MODEL B50-102/B51-102 |
| Classification | Set, Administration, Intravascular |
| Applicant | BIOMEDIX, INC. 23 S. MAIN ST. P.O. BOX 231 Spencer, IN 47460 |
| Contact | Keith E Hoffman |
| Correspondent | Keith E Hoffman BIOMEDIX, INC. 23 S. MAIN ST. P.O. BOX 231 Spencer, IN 47460 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-17 |
| Decision Date | 1996-09-16 |
| Summary: | summary |