The following data is part of a premarket notification filed by Hogan & Hartson with the FDA for Vitaflon Plus/vasculon.
| Device ID | K941417 |
| 510k Number | K941417 |
| Device Name: | VITAFLON PLUS/VASCULON |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | HOGAN & HARTSON 555 13TH ST., N.W. Washington, DC 20004 -1109 |
| Contact | Ulf Lundgren |
| Correspondent | Ulf Lundgren HOGAN & HARTSON 555 13TH ST., N.W. Washington, DC 20004 -1109 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-23 |
| Decision Date | 1994-10-06 |
| Summary: | summary |