The following data is part of a premarket notification filed by Burton Medical Products Corp. with the FDA for Visionary 2000.
| Device ID | K000639 |
| 510k Number | K000639 |
| Device Name: | VISIONARY 2000 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | BURTON MEDICAL PRODUCTS CORP. 21100 LASSEN ST. Chatsworth, CA 91311 |
| Contact | Dorian Swartz |
| Correspondent | Dorian Swartz BURTON MEDICAL PRODUCTS CORP. 21100 LASSEN ST. Chatsworth, CA 91311 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-25 |
| Decision Date | 2000-05-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VISIONARY 2000 74596269 1955947 Dead/Cancelled |
Visionary 2000, Inc. 1994-11-07 |