The following data is part of a premarket notification filed by Rms Div. with the FDA for Elite R/f Spot Film Drive.
Device ID | K902403 |
510k Number | K902403 |
Device Name: | ELITE R/F SPOT FILM DRIVE |
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 | 1990-05-31 |
Decision Date | 1990-08-01 |