The following data is part of a premarket notification filed by Visitec Co. with the FDA for Hessburg Glide Untraocular Lens Guides.
Device ID | K852529 |
510k Number | K852529 |
Device Name: | HESSBURG GLIDE UNTRAOCULAR LENS GUIDES |
Classification | Laser, Ophthalmic |
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 | HQF |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-14 |
Decision Date | 1985-09-24 |