The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Nuclear Associates Knight Sr., Knight Jr. And Sesam Portable Radiography Cassette Holders.
| Device ID | K935397 |
| 510k Number | K935397 |
| Device Name: | NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS |
| Classification | Cassette, Radiographic Film |
| Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
| Contact | Christine L Jess |
| Correspondent | Christine L Jess VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
| Product Code | IXA |
| CFR Regulation Number | 892.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-09 |
| Decision Date | 1993-12-15 |