The following data is part of a premarket notification filed by Visitec Co. with the FDA for Hessburg Light Guard.
Device ID | K853035 |
510k Number | K853035 |
Device Name: | HESSBURG LIGHT GUARD |
Classification | Shield, Eye, Ophthalmic (including Sunlamp Protective Eyewear And Post-mydriatic Eyewear) |
Applicant | VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
Contact | Thomas B Givens |
Correspondent | Thomas B Givens VISITEC CO. 2043 WHITFIELD PARK DR. Sarasota, FL 33580 |
Product Code | HOY |
CFR Regulation Number | 886.4750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-07-18 |
Decision Date | 1985-12-13 |