The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Lead Plastic Viewing Panels.
Device ID | K850816 |
510k Number | K850816 |
Device Name: | LEAD PLASTIC VIEWING PANELS |
Classification | Screen, Leaded, Operator Radiation Protector |
Applicant | VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
Contact | Glasser |
Correspondent | Glasser VICTOREEN, INC. 100 VOICE RD. Carle Place, NY 11514 |
Product Code | EAK |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-02-28 |
Decision Date | 1985-04-10 |