The following data is part of a premarket notification filed by Trumpf Medical Systems, Inc. with the FDA for Trumpf Surgical Lights, Models 301,501,701,1001.
| Device ID | K011693 |
| 510k Number | K011693 |
| Device Name: | TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001 |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | TRUMPF MEDICAL SYSTEMS, INC. 415 JESSEN LN. Wando, SC 29492 |
| Contact | William Apperson |
| Correspondent | Kent Donohue UNDERWRITERS LABORATORIES, INC. 12 LABORATORY DR. Research Triangle, NC 27709 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-05-31 |
| Decision Date | 2001-06-13 |
| Summary: | summary |