The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Nuclear Associates Personnel Protective Shields.
| Device ID | K934850 |
| 510k Number | K934850 |
| Device Name: | NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS |
| Classification | Changer, Radiographic Film/cassette |
| 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 | KPX |
| CFR Regulation Number | 892.1860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1993-11-22 |