The following data is part of a premarket notification filed by Codan Medlon, Inc. with the FDA for Codan Medlon Bc110 Vial Adapter Codan Spike.
| Device ID | K960921 |
| 510k Number | K960921 |
| Device Name: | CODAN MEDLON BC110 VIAL ADAPTER CODAN SPIKE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | CODAN MEDLON, INC. 3325 NORTH GLENOAKS BLVD. Burbank, CA 91504 |
| Contact | Thomas J Bouchard |
| Correspondent | Thomas J Bouchard CODAN MEDLON, INC. 3325 NORTH GLENOAKS BLVD. Burbank, CA 91504 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-06 |
| Decision Date | 1996-04-17 |
| Summary: | summary |