The following data is part of a premarket notification filed by Excelsior Medical Corp. with the FDA for Microbore Extension Set.
| Device ID | K942349 |
| 510k Number | K942349 |
| Device Name: | MICROBORE EXTENSION SET |
| Classification | Set, Administration, Intravascular |
| Applicant | EXCELSIOR MEDICAL CORP. P.O. BOX 297 Long Branch, NJ 07740 |
| Contact | David Lumia |
| Correspondent | David Lumia EXCELSIOR MEDICAL CORP. P.O. BOX 297 Long Branch, NJ 07740 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-17 |
| Decision Date | 1995-02-08 |