The following data is part of a premarket notification filed by Victoreen, Inc. with the FDA for Nuclear Associates Glassers.
Device ID | K934362 |
510k Number | K934362 |
Device Name: | NUCLEAR ASSOCIATES GLASSERS |
Classification | Shield, Eye, Radiological |
Applicant | VICTOREEN, INC. 6000 COCHRAN RD. Solon, OH 44139 -3395 |
Contact | Christine L Jess |
Correspondent | Christine L Jess VICTOREEN, INC. 6000 COCHRAN RD. Solon, OH 44139 -3395 |
Product Code | IWS |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-09-08 |
Decision Date | 1993-11-12 |