The following data is part of a premarket notification filed by Smith & Nephew Equipment Group with the FDA for Shampaine 1000 Series Angenieux Ax-14 Duo,ax-4.
| Device ID | K904965 |
| 510k Number | K904965 |
| Device Name: | SHAMPAINE 1000 SERIES ANGENIEUX AX-14 DUO,AX-4 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | SMITH & NEPHEW EQUIPMENT GROUP 1920 A. JEFFERSON AVE. St. Louis, MO 63104 |
| Contact | Kevin Randich |
| Correspondent | Kevin Randich SMITH & NEPHEW EQUIPMENT GROUP 1920 A. JEFFERSON AVE. St. Louis, MO 63104 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-05 |
| Decision Date | 1991-01-16 |