The following data is part of a premarket notification filed by Skytron, Div. The Kmw Group, Inc. with the FDA for Aurora Led Series Surgical Lights.
| Device ID | K071698 |
| 510k Number | K071698 |
| Device Name: | AURORA LED SERIES SURGICAL LIGHTS |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | SKYTRON, DIV. THE KMW GROUP, INC. 5000 36TH ST., S.E. Grand Rapids, MI 49512 |
| Contact | Larry Perez |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-06-21 |
| Decision Date | 2007-07-06 |
| Summary: | summary |