The following data is part of a premarket notification filed by B. Braun/mcgaw with the FDA for Celsite, Models St401l, St405l.
| Device ID | K994111 |
| 510k Number | K994111 |
| Device Name: | CELSITE, MODELS ST401L, ST405L |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | B. BRAUN/MCGAW 901 MARCON BLVD. Allentown, PA 18103 -9341 |
| Contact | Valerie Lewis |
| Correspondent | Valerie Lewis B. BRAUN/MCGAW 901 MARCON BLVD. Allentown, PA 18103 -9341 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-06 |
| Decision Date | 2000-01-03 |