The following data is part of a premarket notification filed by Excel Medical, Inc. with the FDA for Excelsior Single Lead Dispensing Set.
| Device ID | K913804 |
| 510k Number | K913804 |
| Device Name: | EXCELSIOR SINGLE LEAD DISPENSING SET |
| 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 | 1991-08-26 |
| Decision Date | 1992-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887709080628 | K913804 | 000 |
| 10887709080611 | K913804 | 000 |
| 10887709080604 | K913804 | 000 |
| 10887709080598 | K913804 | 000 |
| 10887709080123 | K913804 | 000 |
| 10887709080116 | K913804 | 000 |
| 10887709080109 | K913804 | 000 |
| 10887709080093 | K913804 | 000 |
| 10887709079752 | K913804 | 000 |