The following data is part of a premarket notification filed by Steris Corporation with the FDA for Amsco Harmony Surgical Lighting And Media System.
| Device ID | K013242 |
| 510k Number | K013242 |
| Device Name: | AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM |
| Classification | Lamp, Surgical |
| Applicant | STERIS Corporation 2720 GUNTER PARK EAST Montgomery, AL 36109 |
| Contact | Robert H Mccall |
| Correspondent | Robert H Mccall STERIS Corporation 2720 GUNTER PARK EAST Montgomery, AL 36109 |
| Product Code | FTD |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-28 |
| Decision Date | 2001-12-13 |
| Summary: | summary |