The following data is part of a premarket notification filed by Burton Medical Products Corp. with the FDA for Model 0450000, Opal Medical Exam Light.
| Device ID | K893808 |
| 510k Number | K893808 |
| Device Name: | MODEL 0450000, OPAL MEDICAL EXAM LIGHT |
| Classification | Device, Medical Examination, Ac Powered |
| Applicant | BURTON MEDICAL PRODUCTS CORP. 7922 HASKELL AVE. Van Nuys, CA 91406 |
| Contact | Swartz |
| Correspondent | Swartz BURTON MEDICAL PRODUCTS CORP. 7922 HASKELL AVE. Van Nuys, CA 91406 |
| Product Code | KZF |
| CFR Regulation Number | 880.6320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-22 |
| Decision Date | 1989-08-15 |