The following data is part of a premarket notification filed by Burton Medical Products Corp. with the FDA for Genesis.
| Device ID | K942553 |
| 510k Number | K942553 |
| Device Name: | GENESIS |
| Classification | Lamp, Surgical |
| Applicant | BURTON MEDICAL PRODUCTS CORP. 21100 LASSEN ST. Chatsworth, CA 91311 |
| Contact | Gretel Lumley |
| Correspondent | Gretel Lumley BURTON MEDICAL PRODUCTS CORP. 21100 LASSEN ST. Chatsworth, CA 91311 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-31 |
| Decision Date | 1994-06-23 |