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 |