The following data is part of a premarket notification filed by Burton Medical Products Corp. with the FDA for Pl Exam Light.
| Device ID | K860088 |
| 510k Number | K860088 |
| Device Name: | PL EXAM LIGHT |
| Classification | Lamp, Surgical |
| Applicant | BURTON MEDICAL PRODUCTS CORP. 7922 HASKELL AVE. Van Nuys, CA 91406 |
| Contact | Tim Boatman |
| Correspondent | Tim Boatman BURTON MEDICAL PRODUCTS CORP. 7922 HASKELL AVE. Van Nuys, CA 91406 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-10 |
| Decision Date | 1986-01-24 |