The following data is part of a premarket notification filed by Excel Medical, Inc. with the FDA for Vented Needle.
| Device ID | K932462 |
| 510k Number | K932462 |
| Device Name: | VENTED NEEDLE |
| Classification | Set, I.v. Fluid Transfer |
| Applicant | EXCEL MEDICAL, INC. P.O. BOX 1353 Asbury Park, NJ 07712 |
| Contact | Margaret Lumia |
| Correspondent | Margaret Lumia EXCEL MEDICAL, INC. P.O. BOX 1353 Asbury Park, NJ 07712 |
| Product Code | LHI |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-21 |
| Decision Date | 1993-09-15 |