The following data is part of a premarket notification filed by Castle Co. with the FDA for Daystar Selectra & Selectra/orbiter.
Device ID | K780666 |
510k Number | K780666 |
Device Name: | DAYSTAR SELECTRA & SELECTRA/ORBITER |
Classification | Light, Surgical, Ceiling Mounted |
Applicant | CASTLE CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FSY |
CFR Regulation Number | 878.4580 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-03-10 |
Decision Date | 1978-04-27 |