The following data is part of a premarket notification filed by Paul B. Elder Co. with the FDA for Phototherapy Light Chamber.
| Device ID | K810358 |
| 510k Number | K810358 |
| Device Name: | PHOTOTHERAPY LIGHT CHAMBER |
| Classification | Cabinet, Phototherapy (puva) |
| Applicant | PAUL B. ELDER CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KGL |
| CFR Regulation Number | 878.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-02-10 |
| Decision Date | 1981-03-20 |