The following data is part of a premarket notification filed by Rms Div. with the FDA for Sfd-035 Spot Film Device.
| Device ID | K902146 |
| 510k Number | K902146 |
| Device Name: | SFD-035 SPOT FILM DEVICE |
| Classification | Device, Spot-film |
| Applicant | RMS DIV. 2301 WINDSOR CT. Addison, IL 60101 |
| Contact | William J Engel |
| Correspondent | William J Engel RMS DIV. 2301 WINDSOR CT. Addison, IL 60101 |
| Product Code | IXL |
| CFR Regulation Number | 892.1670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-14 |
| Decision Date | 1990-05-31 |