The following data is part of a premarket notification filed by Commercial Products & Engineering Co. with the FDA for Floor Light.
Device ID | K882333 |
510k Number | K882333 |
Device Name: | FLOOR LIGHT |
Classification | Light, Surgical, Floor Standing |
Applicant | COMMERCIAL PRODUCTS & ENGINEERING CO. 5001 KENDRICK, S.E. Grand Rapids, MI 49512 |
Contact | John Lomonaco |
Correspondent | John Lomonaco COMMERCIAL PRODUCTS & ENGINEERING CO. 5001 KENDRICK, S.E. Grand Rapids, MI 49512 |
Product Code | FSS |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-06 |
Decision Date | 1988-06-23 |