The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Clear-pb Lead Plastic Overhead Barrier 56-628.
| Device ID | K952233 |
| 510k Number | K952233 |
| Device Name: | CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 |
| Classification | Screen, Leaded, Operator Radiation Protector |
| Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
| Contact | Linda S Morin |
| Correspondent | Linda S Morin VICTOREEN, INC. 6000 COCHRAN RD. Cleveland, OH 44130 -3304 |
| Product Code | EAK |
| CFR Regulation Number | 892.6500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-12 |
| Decision Date | 1995-06-16 |