The following data is part of a premarket notification filed by Viox Corp. with the FDA for Lead Glass Shields.
Device ID | K872656 |
510k Number | K872656 |
Device Name: | LEAD GLASS SHIELDS |
Classification | Holder, Syringe, Lead |
Applicant | VIOX CORP. 6701 SIXTH AVE. SOUTH Seattle, WA 98108 |
Contact | Thomas W Burnett |
Correspondent | Thomas W Burnett VIOX CORP. 6701 SIXTH AVE. SOUTH Seattle, WA 98108 |
Product Code | IWR |
CFR Regulation Number | 892.6500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-07 |
Decision Date | 1987-07-16 |